Category Archives: MHRA Alerts

Urgent field safety notice: recall of specific lots of Accu-Chek® Aviva / Performa test strips

May 2018 Roche Diabetes Care has alerted us that they are recalling specific lots of Accu-Chek Aviva test strips and Performa test strips. This information has been shared directly with users for whom Roche have contact details and has also … Continue reading

Posted in MHRA Alerts | Tagged , | Comments Off on Urgent field safety notice: recall of specific lots of Accu-Chek® Aviva / Performa test strips

MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – risk of alarm failure

20 September 2017 Roche Accu-Chek Insight insulin pumps – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump. All patients and carers using the Accu-Chek Insight … Continue reading

Posted in MHRA Alerts | Tagged , | Comments Off on MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – risk of alarm failure

MHRA Field Safety Notice: Medtronic Infusion sets (specific lot numbers)

September 2017 Medtronic MiniMed Infusion Sets – Recall of Specific Lot Numbers – Potential over-delivery of insulin Medtronic voluntarily recalled specific lots earlier this month. Every Medtronic pump users should have been contacted by now. The specific lot numbers are: … Continue reading

Posted in MHRA Alerts | Tagged , | Comments Off on MHRA Field Safety Notice: Medtronic Infusion sets (specific lot numbers)

MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – updated information for battery management

2 May 2017 Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion. – click on this headline to see the full notice. … Continue reading

Posted in MHRA Alerts | Tagged , | Comments Off on MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – updated information for battery management

MHRA warns against accepting trial of new insulin pumps by direct message on social media

Company adverts for new diabetes technology are a good way to find out what’s available and what might be coming. Responding to an advert and asking for information is also good. However, if you are invited by direct message on … Continue reading

Posted in MHRA Alerts | Comments Off on MHRA warns against accepting trial of new insulin pumps by direct message on social media

MHRA: Medical device alert – Roche Accu-Chek Insight insulin pump

Published 1 September 2016 Accu-Chek® Insight Insulin pump system: risk of over- or under-infusion of insulin Manufactured by Roche Diabetes Care – inadequately detailed handling instructions of the ‘Key Lock’ function of the pump may lead to unintentional operation, which … Continue reading

Posted in MHRA Alerts | Comments Off on MHRA: Medical device alert – Roche Accu-Chek Insight insulin pump

MHRA: Medical device alert – Roche Accu-Chek Insight insulin pump with NovoRapid cartridges

Date issued: 15 August 2016 Accu-Chek® Insight insulin pump system manufactured by Roche Diabetes Care with NovoRapid® PumpCart® cartridges – risk of hyperglycaemia. Cartridges inserted incorrectly can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin, which … Continue reading

Posted in MHRA Alerts | Comments Off on MHRA: Medical device alert – Roche Accu-Chek Insight insulin pump with NovoRapid cartridges

MHRA: Medical device alert – TRUEresult & TRUEtrack blood glucose test strips

Issued 10 August 2016 Manufactured by Nipro Diagnostics, certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia. This Alert refers to different blood glucose test strips to those covered by MDA/2016/009R. … Continue reading

Posted in MHRA Alerts | Comments Off on MHRA: Medical device alert – TRUEresult & TRUEtrack blood glucose test strips

MHRA: Medical safety alert – Accu-Chek Insight insulin pump

Issued 12 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’. Users are advised to … Continue reading

Posted in MHRA Alerts | Comments Off on MHRA: Medical safety alert – Accu-Chek Insight insulin pump

MHRA: Field Safety Notice – Dexcom G4 Platinum and G5 Receivers

Dexcom have noticed an increase in complaints related to audible alarms and alerts associated with G4 and G5 receivers. Therefore they are notifying all Dexcom customers that you may not be able to hear an intended alarm or alert, meaning … Continue reading

Posted in MHRA Alerts | Comments Off on MHRA: Field Safety Notice – Dexcom G4 Platinum and G5 Receivers