Аналіз інформації за період 01.05.2016 – 30.06.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 04.07.2016 о 00:00


Великобританія

https://www.gov.uk/drugdevicealerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

·         Nipro Diagnostics TRUEyou blood glucose test strips – risk of false low blood glucose results in some batches

(Nipro Diagnostics) TRUEyou blood glucose test strips – certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia (MDA/2016/009)

Alert type:

Medical device alert

Issued:

30 June 2016

·         Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine

False low results may occur in a range of clinical chemistry tests in specimens drawn from patients treated with N-acetylcysteine (NAC) due to the interference with specific assays utilised by Siemens ADVIA instruments.

Alert type:

Medical device alert

Issued:

22 June 2016

·         Four Bipolar QuickSite and QuickFlex lead models – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation

Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.

Alert type:

Medical device alert

Issued:

21 June 2012

·         CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion

All devices with an expiration date on or before 31 March 2021 are at risk of under-infusing so we advise users to undertake a risk assessment before using them. (MDA/2016/006)

Alert type:

Medical device alert

Issued:

24 May 2016

·         Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment

Risk of a hypoglycaemic event if users misinterpret maintenance message ‘M-83 pump not able to complete task’.

Alert type:

Medical device alert

Medical specialism:

General practice

Issued:

12 May 2016

 

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