BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1444481 · Received August 18, 2009

    Report

    Report Number
    MW5012478
    Event Type
    Other
    Date Received
    August 18, 2009
    Report Date
    August 14, 2009
    Manufacturer
    ROCHE DIAGNOSIS
    Product Code
    LFR
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MONITOR SEEMS TO BE INACCURATE. TOOK GLUCOSE TEST - READ 177. TOOK 1 MINUTE LATER (CHANGED LANCET AND TESTING STRIP) READ 97. HAVE RECHECKED MANY TIMES AND IT IS OFF EVERY TIME. ONE DAY READ 360, RETOOK IT, AND IT WAS 124. DIAGNOSIS: DIABETIC TYPE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA GLUCOSE METER LFR ROCHE DIAGNOSIS

    Patients

    Seq Age Sex Outcome Treatment
    1