Insulin Safety Alert Pump Medtronic

Those that I have now are not affected.
You can enter the link and check your

DiabetesForo
07/02/2013 2:04 a.m.

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Thanks, Owash ... always on the edge of the news;)

I have proven my lots and one of them is defective.I have already spoken with Medtronic and they will replace them with others.

Velia
07/02/2013 6:34 a.m.

De los buenos tiempos, siempre quiero más...
Mamá de Ángela, ¡16 añitos, fiera!. Debut: octubre de 2003.
Bomba insulina Medtronic Paradigm Veo desde junio 2005
Última hemo 6.1

Proven and I have none affected.

Thanks Owash

DiabetesForo
07/02/2013 12:52 p.m.

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Well, China has touched us, because we did not have 1 lot affected, but 2: shock: .... The fact is that we only have 1 reservoir, with which the rest have been used ...
That we have had Hiper abnormal, yes, specifically the 2 previous changes in Angela's infusion equipment ... that is for the reservoirs, or pajolera idea ...

Velia
07/03/2013 7:17 a.m.

De los buenos tiempos, siempre quiero más...
Mamá de Ángela, ¡16 añitos, fiera!. Debut: octubre de 2003.
Bomba insulina Medtronic Paradigm Veo desde junio 2005
Última hemo 6.1

Well, I also have another affected lot.
I picked it on Tuesday, but until yesterday I didn't even look at it ... and bingo: Evil:

Yesterday afternoon I was calling Medtronic but there was no way.
Today, from the hospital, I first called line 901 ... They had no idea.They simply took note and that I would be a message.
Tremendous.

And then I called the Iberian Medtronic.
There they knew everything that happened.
They took note of everything: personal data, bomb, affected lot ...
That they would directly throw the affected lot and they would call me to give me a new one: shock:

I asked him why the drug agency had not given any alert ... and he didn't know how to say anything.
That the alert was given since Tuesday and that a letter would arrive from home from the hospital.
But of course, the hospital has no idea because I have informed you:-/:-/: shock :: shock :: shock:

Via Twitter, the official Medtronic Spain account, confirms everything they have told me by phone.

I must be very exaggerated and tremendous, but that an urgent health alert afternoon 1 week (as little) in reaching patients seems shameful.

DiabetesForo
07/05/2013 1:29 p.m.

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Ah, and another head scratch.

If there is a risk of insulin leakage, it would occur with the connected and operating pump, it would not be loaded by loading the insulin reservoir
Therefore, insulin would fall within the system, right?endangering the normal functioning of the pump ...

DiabetesForo
07/05/2013 1:33 p.m.

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It must be that I am pessimistic and I see everything black, but what is happening (because the problem explained in this post is still unresolved) surpasses me.

I do not understand how an urgent health alert is not disseminated by the AEMPS.
I do not understand why Medtronic does not directly communicate the problem to scientific societies and patient associations for maximum dissemination.
I do not understand why Fede is dedicated to retweeting idiocies since Thursday and despite asking for it 2 times he is unable to spread the alert.
I do not understand why not a single patient association has spread this problem.

The feeling is half disbelief half indignation.

Thanks to some of you, I have been able to find out about the problem.
Thanks to knowing you, I am aware of problems, solutions, prevention, many things related to diabetes.

When truly important situations arrive, almost everyone looks the other way, well rather they look only at their interests.

Right now I am the Kamikaze driver who goes against the direction on the highway with all cars.
Something should have done wrong.

DiabetesForo
07/07/2013 1:28 p.m.

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No, you are not doing anything wrong, on the contrary, if it is not for you I do not find out what happens, that is what is wrong, that we find out so, on Friday I have to go to the hospital for consumables, I goTo say it, how much do you bet that nobody knows anything ????????????????????????????????????: Twisted:
Anyway, I am reaching a point that everything outrages me ..... and I no longer know if I exaggerate or what ....;)

DiabetesForo
07/07/2013 1:35 p.m.

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Owash, I hadn't read that TB.You had an affected lot ... I don't even know what I read:-/ ... well, you don't do wrong, I wouldn't have learned about you either ... thanks !!! ... and withRegarding the associations, you see, they are because there must be to, but come on, they are worth them.
As for the loss of insulin inside the pump, Puffff, we broke a 6 months ago, motor error.They told us that if they had fallen and such, but not ... to know each other ... there are things that it is almost better not to think, and with that it is not that he is throwing his head the other way ... but come on, there is noAnswer, so ...
Ah, and as for the neglect of the admon, association and others, we will include that of some patients/users ... I have specifically notified a few and any of them has not done me or p.case .... asinque, do not climb, handsome !!!!

Velia
07/08/2013 4:12 a.m.

De los buenos tiempos, siempre quiero más...
Mamá de Ángela, ¡16 añitos, fiera!. Debut: octubre de 2003.
Bomba insulina Medtronic Paradigm Veo desde junio 2005
Última hemo 6.1

I hit the answer that the Spanish Agency for Medicine and Health Products (AEMPS) has given me

estimated Mr.
In relation to your consultation we want to inform you that the Medtronic Iberica company informed the Health Products Surveillance Unit of the Spanish Agency for Medicines and Health Products (AEMPS), from the withdrawal of the market of certain lots of insulin reservoirs, MMT models-325A and MMT-332A of the paradigm infusion pumps.

On Tuesday, July 2, 2013, the AEMPS gave its compliance to the Medtronic Iberica company to proceed with the dissemination of warning notes addressed to both health professionals and patients who have the products affected in our country.

The AEMPS is carrying out the evaluation of all the information related to this corrective field safety action and will proceed to the transmission of alert to all the points of contact of surveillance of health products of the CCAA.From the moment of the reception, the points of surveillance of health products of the autonomous communities must activate their action procedures in order to ensure that the dissemination is carried out with the agreed criteria, regardless of whether those responsible forAn autonomous community can carry out other complementary actions.

Finally we inform you that it will be published soon on the AEMPS www.aemps.gob.es

That is, if I understand well, Medtronic communicated before July 2 the "incidence" to the AEMPS and it was July 2 when the AEMPS authorized him to make the notes of warning to professionals and patients.
The problem has been ... as I imagined

today the AEMPS has not even sent the alert to the CCAA: shock :: shock::-/:-/: ((: (((
It is to cry.

Today is day 8.
I have not received anything as an affected patient.
In my hospital I informed them last Friday ... and it is tomorrow, when they will officially communicate something;1 week later ... 1 week

And when Canas have left us and summer has passed, AEMPS using Internet tip technology and online environment will publish the informative warning note on its website.
Marvelous.

I remember that it is an urgent note ... it does not become urgent and there by 2025 the same said something.

To the patient they give.
Total, we just make claim and spend.

I need to collect information from my Ministry of Health ... that I suppose do not respond to my email because they have no idea, reading the text above I understand them perfectly.

DiabetesForo
07/08/2013 1:10 p.m.

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Thank you Oswash I have given the notice to the parents of the association any has the son of camping that I have in use is not affected but the one I have spent I have not spent it, I already spent it anyway thanks for Visa for that if it is notFor you as I find out.

samozeus
07/08/2013 3:25 p.m.

DM1 desde el 81 antes de naranjito.
Con bomba desde 2012
Minimed Veo parading
Minimed 640g desde 06/2015
Minimed 640g desde 19/03/2016 la 2a
Minimed 780g desde el 23/03/2021
Hemoglobina 12/01/2021->6.1
28/07/2021-> 6.4

Only 1 week later, the AEMPS has been well issued by the security note.
Link ... radigm.htm
Identification of several problems related to certain batch of insulin reservoirs and all infusion equipment used with the "paradigm infusion pumps"

Publication date: July 9, 2013

Category: Health products, security.
Reference: PS, 9/2013

The AEMPS reports the identification of several problems related to both insulin reservoirs, and with all infusion equipment used with paradigm infusion pumps, manufactured by Medtronic Minimed, USA, which have led to the market withdrawalof the reservoirs and to the modification of the instructions for use of the infusion equipment.

The Spanish Agency for Medicines and Health Products (AEMPS) has been informed by the Iberian Medtronic company, with two problems with reservoirs and infusion equipment of the paradigm insulin pumps, which could lead to an incorrect insulin dosage.

The problems detected are detailed below:

Greater risk of leaks in certain lots of insulin reservoirs, MMT-326A and MMT-332A models, which could cause the administration of less insulin of the desired and in case of occlusion, the pump alarm may not be activated.
According to the information provided by Medtronic, this greater probability of escape is related to an unusual wear of one of the manufacturing tools used in the production of a component of the lots of affected reservoirs.

The company is sending a warning note (reference: FA586) to inform, both health professionals and withdrawal of the market of the affected insulin reservoirs.

Temporary block of the ventilation holes of infusion equipment, which could produce the administration of an overdose or insulin infraadosis.
According to the information provided by the company, if insulin or other liquid spills on the top of the reservoir when it is extracted from the transfer protector after filling the reservoir with an insulin vial, the ventilation holes of the ventilation could temporarily blockConnector that allow the correct barley of the pump and administer more or less insulin of the due.

The company is sending a warning note (reference: FA577) to inform, both health professionals and patients who have the affected product, the recommendations to be followed to prevent the blockage of ventilation holes and the update of the update of updateThe instructions for use that will include these recommendations.

Identification of affected products

Lot numbers of insulin reservoirs,
MMT-326A and MMT-332A models affected
H8416432 H8461538 H8489386 H8512826
H8420977 H8463297 H8491921 H8515317
H8422490 H8464121 H8492449 H8517079
H8424676 H846788 H8494645 H8521052
H8437486 H8469703 H8496561 H8539013
H8441420 H8471745 H8500423 H8541843
H842973 H8473106 H8500472 H8584244
H8451531 H8473271 H8503372 H862774
H8452933 H8476270 H8503728 H8603292
H8455959 H8478398 H8509305 H8604958
H8457716 H8485398 H8510440 H8635301
H8459557 H8486688 H8512566
Recommendations

Patients:
Reservoir related problem
1.1 If you have reservoirs affected by the withdrawal

Do not use these reservoirs.Use only the unabled reservoirs.In the event that you are left without reservoirs, contact your doctor to receive the necessary recommendations for the control of your glycemia, andGo to alternative treatment with insulin injections prescribed by your doctor.
Contact your doctor immediately if you experience any of the following symptoms: nausea, vomiting, lack of air and thirst/excessive urination.
The reservoirs that have not been used and that are affected by this withdrawal must discard.
The instructions to request replacement reservoirs are explained in the company's notice note and on the Medtronic website: Link
1.2 If the lot numbers of the reservoirs available are not included in the list, you can use these reservoirs, since they are not affected by the withdrawal of the product.

Problem related to the infusion equipment:
To prevent the liquid from blocking the connector ventilation holes:

After filling the reservoir, make sure the insulin vial is vertical when the blue transfer protector reservoir is removed.Thus, insulin will not accidentally reach the top of the reservoir and will pass to the tube connector.
If any liquid reaches the upper part of the reservoir or inside the tube connector, discard these components and start the procedure with another reservoir and a new infusion equipment.
Health professionals:
Identify patients who use paradigm insulin pumps and inform them of both problems.
In the event that the patient does not have replacement reservoirs, he provides the necessary recommendations for the maintenance of blood glucose until he receives the new reservoirs.
Health professionals can communicate any incident related to the affected product, according to the procedure established in the guidelines for the application of the surveillance system by the centers and health professionals (Ref.: AEMPS/CTI-PS/October 2010) and the formsrelated.

DiabetesForo
07/09/2013 2:14 p.m.

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Minimizing this alert, as they have tried to do is very serious.
As much as the incidence has been small .... But the "motor errors" do not think they are casual.
I have already told me 3 cases in recent months ...

The null diffusion of alert is a tremendous situation.
If the legality in which the AEMPS moves is this that we are seeing ... we have a serious problem.
If the legality in which companies must solve urgent problems is this that we are seeing ... we have the 2nd serious problem.

If the commitment of social agents is what we have seen in this case, we have the third serious problem.

But, of course, then when you talk to who, I am that I am an exaggerated and the subject is not so much.
Send eggs.

DiabetesForo
07/09/2013 2:21 p.m.

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Well, I have uploaded the news to Meneame.
It is the last thing I'm going to do on this subject.I don't feel like doing anything else.
I'm very fed up.
Those who care about you already know the news.

To the rest that Espabile, if they challenge them.

DiabetesForo
07/09/2013 5:03 p.m.

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Hello, I am new in this, and I am a little pissed off, because this afternoon they have notified me of the health center that some lots had to be removed from the reservoir and what has been my surprise to discover that I have five affected, and I wonder,Since when do they know?And why haven't you alerted? ...

ccloti
07/12/2013 7:46 p.m.

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Yesterday they called me from Medtronic to ask me for direction and send me the new reservoirs.
It is not bad, it has taken 1 week to return the call.

Nothing is known about the letter to let me know about the problem ... they don't even warn, how much, what does it happen?

DiabetesForo
07/13/2013 6:46 a.m.

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To those who have Medtronic bombs.
Could you confirm that the Hospital or Medtronic letter has arrived announcing the problem?
It doesn't matter if you have affected lots or not ... They should send you the letter the same.

Today I have not received anything ... and it doesn't seem normal.

DiabetesForo
07/18/2013 6:33 a.m.

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I have not received anything either and I have already said it, if it is not for you I do not find out anything

DiabetesForo
07/18/2013 7:30 a.m.

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At the moment nothing at all !!!The week I will call Medtronic to see what it counts.

Velia
07/19/2013 5:55 a.m.

De los buenos tiempos, siempre quiero más...
Mamá de Ángela, ¡16 añitos, fiera!. Debut: octubre de 2003.
Bomba insulina Medtronic Paradigm Veo desde junio 2005
Última hemo 6.1

Good night to everyone.It does not pass by here and today I have received news of the forum update and I have decided to pass again.

Owash said:
to those who have Medtronic bombs.
Could you confirm that the Hospital or Medtronic letter has arrived announcing the problem?
It doesn't matter if you have affected lots or not ... They should send you the letter the same.

Today I have not received anything ... and it does not seem normal.

Via
07/22/2013 9:49 p.m.

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