The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert in relation to Accu-Chek blood glucose monitoring systems.
The MHRA is reporting a risk for strip error messages and false high and low blood glucose results with Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips. Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.
Healthcare personnel who manage patients using these devices are advised to identify patients using Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Aviva Expert, Accu-Chek Aviva Combo, Accu-Chek Aviva Insight, Accu-Chek Performa Nano meters. Patients should be advised to discontinue use of Accu-Chek Aviva and Accu-Chek Performa blood glucose test strips with affected lot numbers:
Accu-Chek Aviva Strips (50s)
497392
497391
496915
496809
496802
496807
Accu-Chek Aviva Strips (10s)
497344
497392
Accu-Chek Performa Strips (10s)
476597
476646
Accu-Chek Performa Nano mmol Kit. (Performa 10 test strips contained within the kit)
10153116
10153114
10153115
10153112
10153111
The MHRA says healthcare professionals must ensure that patients can continue to monitor their blood glucose effectively and that they have an alternative testing means if required.
