Accu-Chek Aviva Combo Meter and Accu-Chek Performa Combo Blood Glucose Meter 의 안전성 경고

Safety alert

2013-11-05

2013-11-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131105.html

Medical device safety alert: roche accu-chek aviva combo meter and accu-chek performa combo blood glucose meter the medicines and healthcare products regulatory agency (mhra), united kingdom has issued a medical device safety alert concerning accu-chek blood glucose meters, manufactured by roche diagnostics gmbh. the affected devices are identified as follows: accu-chek aviva combo meter: all serial numbers xxx 10200001 and higher (only the last 8 digits of the serial number to be considered) accu-chek performa combo meter: all serial numbers xxx 20200001 and higher (only the last 8 digits of the serial number to be considered) the manufacturer has become aware that in rare cases the accu-chek aviva combo/accu-chek performa combo blood glucose meter’s bolus advisor function can potentially recommend a correction bolus amount less than the amount that should have been recommended. the issue can only occur in the case that the user confirms delivery of a “manual pump” bolus on the blood glucose meter. for normal use of the product where a bolus is recommended by the meter’s bolus advisor and administered wirelessly via the pump, the accu-chek combo system can be used safely and reliably as normal. the issue has no impact on the basal rate and the meal boluses of the system. they are delivered as intended. the issue only impacts the correction boluses calculated by the bolus advisor to lower elevated blood glucose levels. the occurrence of this issue is only possible if the user confirms delivery of a “manual pump” bolus on the blood glucose meter, and does not complete the task of delivering the bolus manually via the pump, or delivers a bolus amount manually via the pump which differs from the amount the user entered on the meter for manual delivery, or delivers a bolus of any amount manually via the pump more than 10 minutes after the bolus record is entered in the meter. in subsequent bolus calculations during the insulin acting time, the system could recommend less insulin than is actually needed to lower blood glucose levels, leading to temporary mild hyperglycemia (elevated blood glucose levels). the manufacturer asks users to be aware of the above scenario and to always deliver the exact bolus amount, as entered in the blood glucose meter, manually on the pump within 10 minutes, as described in the accu-chek aviva combo advanced owner’s booklet or accu-chek performa combo advanced owner’s booklet. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con329294 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 november 2013.