DEXCOM G4 health alert

Link

I reproduce here, it is basically a warning of possible failure for alerts due to down or glucose rise

2016

You can consult this information in PDF format

Possibility of not receiving an acoustic alarm or alarm from the receptors of continuous glucose monitoring systems Dexcom G4 Platinum

Publication date: March 21, 2016

Category: Health products, security.
Reference: PS, 4/2016

The AEMPS reports the possibility of not receiving an acoustic alarm or alarm of the receptors of the continuous glucose monitoring systems dexcom G4 Platinum, manufactured by Dexcom Inc., USA, and an episode of hypoglycemia or ofHyperglycemia

The Spanish Agency for Medicines and Health Products (AEMPS), has been informed by the company DEXCOM INC, USA, of the possibility of a failure in the speaker of the receptors of the continuous monitoring systems of glucose Dexcom G4 Platinum.If an alerts or acoustic alarms are scheduled as notice, a hypoglycemic episode (low glucose) or hyperglycemic (high glucose) may not be detected acousticly detected.

The Dexcom G4 Platinum's continuous glucose monitoring system is a glucose monitoring device designed to identify trends and monitor patterns in people (2 or more years) with diabetes.The system includes the sensor, the transmitter and the receiver.The sensor is an enzymatic electrochemical collector that measures glucose into the interstitial fluid, is introduced under the skin and monitors glucose levels for a maximum of 7 days.The transmitter is a reusable device that sends to the receiver (wirelessly) the information on the glucose measured by the sensor.The receiver is a portable device that receives and shows glucose readings and trend information, alerting whether values ​​are reached above or below fixed limits.

Current situation in Spain

The manufacturer company has sent a warning note to health professionals and patients who have the Platinum dexcom systems, informing the problem detected and in which it remembers the importance of periodically checking the alarms and alerts of the receiver to ensure that they work correctly.

Affected products

Dexcom G4 Platinum Rectors:

Reference number
DESCRIPTION OF THE COMPONENT
MT20649-1
Dexcom G4 Platinum Receptor (mg/dl)
manufactured by Dexcom Inc, USA.

Image of the Receiver of the Continuous Glucose Monitoring System Dexcom G4 Platinum

These products are distributed in Spain through companies:

Novalab Ibérica S.A.L., located on Argentina 2, ship A10, 28806 Alcalá de Henares, Madrid.

Roche Diabetes Care Spain S.L., located in Avenida de la Generalitat 164-165, 5a, E-08174 Sant Cugat del Vallès, Barcelona.

Recommendations

Health professionals
Contact patients who are using the continuous glucose monitoring systems DEXCOM G4 Platinum, to deliver the company notice note and inform them of the need to periodically check the alarms and alerts of the receiver to ensure that they work correctly.

Patients
If you are a diabetic patient who is using a continuous glucose monitoring system of the G4 Platinum glucose:

If you have not received the company's note, contact your health professional to provide it.
Periodically check the alarms and alerts of your receiver to make sure they work correctly (especially if the receiver gets wet or receives a blow).The instructions to test alarms and alerts are found together with the company notification, as well as in the user's guide.
YeahNote that the alarms and acoustic alerts of your receiver do not work properly, or if you have any questions about this notification, see Link to replace the receiver.If you cannot access the website, contact the company that has supplied the product.
Company data

Novalab Ibérica S.A.L.

Argentina 2, ship A10,

28806 Alcalá de Henares, Madrid

Customer Service Telephone: 91 802 45 15

www.novalab.es

ROCHE DIABETES CARE SPAIN S.L.

Avenida de la Generalitat 164-165, 5th

E-08174 Sant Cugat del Vallès, Barcelona.

Customer Service: 900 210 341

www.accu-check.es

If you want to locate information related to the content of this page, use the search engine

Well, my girl has one of those receptors, so I have filled the form and the attached message has appeared.They do not indicate how long we will take to receive it.

By the way, I did not know that ACCU-CHECK also markets it in Spain, does anyone know what price the sensors sell?

@Con_q_de_quimica but have you filled it because it failed you?

@jconegar yes, but the alarm of 55, in principle I click to see more information, indicate a series of steps and did not sound.The receiver changed it recently and luckily until now he had never reached that level, he always realizes when he vibrates.

Last week there was an alert that did not sound, so far we thought that as it had been at night I would have turned off without realizing it.

I'm going to try mine, which as I carry the bomb I don't use it, but if this evil I want to be clearly fixed.

jconegar said:
I am going to try mine, which as I carry the bomb I do not use it, but if this bad I want them to be clearly fixed.

If it coincides with the reference number MT20649-1 do it as soon as possible, with the money that the Dexcom costs what less than it works perfectly.

So is just that specific lot, right?

I hope that Novalab sends an email to everyone who has bought it, and if they do not answer to be called urgently.

@Arotorias I have my doubts about that, I have learned for this forum, so far I have no Novalab news ...

Milks, mine also of that lot !!I am going to look at him when I come from working, that now that I read it if it is true that I have gotten up a little high and did not remember that the high alarm had sounded, I thought how @con_q_de_quimica that would have turned off without realizing it.
I am reading the page, the line that can fail is only the one of 55 or also the rest of the alarms?
@Con_q_de_quimica, when did you try 55, did nothing?

gala said:
milk, mine also of that lot !!I am going to look at him when I come from working, that now that I read it if it is true that I have gotten up a little high and did not remember that the high alarm had sounded, I thought how @con_q_de_quimica that would have turned off without realizing it.
I am reading the page, the line that can fail is only the one of 55 or also the rest of the alarms?
@Con_q_de_quimica, when you tried the one of 55, did nothing ??

Yes that vibrates, but it does not whistle, on the page it puts the following: reference numbers and descriptions of the DEXCOM receptors

The receiver's piece number is located on the back of the same:

REFERENCE NUMBER DESCRIPTION OF THE COMPONENT
MT20649-1 DEXCOM G4 PLATINUM Receiver (mg/dl)
MT20649-2 Dexcom G4 Platinum Receiver (mmol/L)
MT22719-1 DEXCOM G5 Receiver (mg/dl)
MT22719-2 DEXCOM G5 Receiver (mmol/L)
Receiver's alarms and alert test instructions

Use the “Test” function in the Main Menu Option of the Receiver Menu to test your acoustic alarms and alaries:

Press the central receiver button to access the main menu
Move down to profiles
Select profiles
Scroll down until performing a test
Select Test
Show down to the low level fixed alarm of 55 (for mg/dl) or the low level fixed alarm of 3.1 (for mmol/l) as appropriate to its type of receiver
Select the low level fixed alarm of 55 or 3.1 that is applied to your type of receiver
Check that you receive the first vibrations (vibratory part of alarm) and then the beeps (acoustic part of the alarm)
Follow the previous instructions to test your receiver and choose the appropriate response below.

I just tested at mine, is it from the MT20649-1 series, both the vibration and the sound have worked well, do I have to do some more test?, Or do I do it for good?:-/

fer said:
I just tested at mine, is from the series MT20649-1, both vibration and sound have worked well, I have to do some more test?, or what do II do good?:-/

@Fer in theory you can give it for good ...

Although as @Gala has commented, what seems to me that it has not ever sounded and has missed me, it has also happened to me, so I will "watch" for a while, in case it is not something that always fails./:)

Well, a couple of days have been since I sent the form and we continue without news from anyone ...

I would call them by phone because namely that survey is going.Do you have your phone?the one in Madrid?

jconegar said:
I would call them by phone because namely where that survey is going.Do you have your phone?Madrid?

Well, it is assumed that the US, but now several holidays come, I imagine that until next week I will not have news.

@Con_q_de_quimica, you have known something from those of Dexcom or Novalab, mine if it sounds, as it distorts the speaker a lot, it seems that it is hoarsThey have not answered you ...

@Gala did answer me, in the end they did not change it because it was an error on our part;We did the test with the descent alert instead of the 55, the descent could not sound because it was in vibration .. 8-}

With the money that costs, if he is in guarantee and does not sound good to you I would call Novalab.

@Con_q_de_quimica, the vibration sounds exaggeratedly is heard throughout the house, if I take it in my bag, everyone finds out, like the speaker distorted, yours in vibration sounds a lot?I no longer remember how it sounded at the beginning but I think it was not so much ...