Lifescan OneTouch Verio Pro, Lifescan OneTouch Verio IQ 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/022

CON261794

2013-04-11

2013-04-11

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON261794?tabName=allTabs

Recall of one touch verio meters because of a software fault at glucose levels of 56.8mmol/l and above. one touch verio pro: at very high blood glucose concentrations a falsely low result will be displayed. one touch verio iq: at very high blood glucose concentrations no result will be displayed. lifescan has notified the mhra of a software problem affecting the one touch verio pro and one touch verio iq blood glucose meters. onetouch verio pro: displays an incorrect result and stores this incorrect result in the memory. at extremely high blood glucose levels (56.8mmol/l and above), the incorrect result will be 56.8mmol/l lower than the measured result. onetouch verio iq: no result will be displayed, and no result will be stored in the memory. at extremely high blood glucose levels (56.8mmol/l and above), the meter will countdown then turn off instead of displaying a result. lifescan is recalling all onetouch verio blood glucose meters manufactured up to the 07 march 2013 and has written to patients and relevant healthcare professionals i.E. diabetes specialist nurses, gps, practice nurses and pharmacists. one touch verio pro and one touch verio iq meters are capable of reporting results in the range 1.1 – 33.3mmol/l. the performance of the test strips is not affected by this problem. this problem also affects the onetouch verio pro+ device, which is used by health professionals only. lifescan has issued a field safety notice concerning this to all affected customers. this problem does not affect any other blood glucose meter supplied by lifescan.

Advise users of affected meters to contact Lifescan customer services on 0800 279 9118. Pharmacists supplying OneTouch Verio meters or OneTouch Verio test strips: Do not supply any affected OneTouch Verio meters. If you have any affected OneTouch Verio meters in your current stock contact LifeScan customer care for replacements. When dispensing OneTouch Verio test strips advise users with affected meters to contact LifeScan customer care for a replacement meter, and provide a copy of the relevant customer letter (see appendix). Healthcare professionals who manage patients who use OneTouch Verio meters: Identify patients who are using affected meters. Advise users of affected meters to contact LifeScan customer care for a free replacement. Pharmacists supplying these devices or OneTouch Verio test strips. Healthcare professionals who manage patients who use these devices.