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
· 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