BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760954 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06185
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF 331 MG/DL ON THE ADVANTAGE SYSTEM. PATIENT STATED THAT BLOOD GLUCOSE WAS IMMEDIATELY RETESTED ON A PHYSICIAN'S DEVICE WITH A RESULT OF 98 MG/DL. NO PATIENT INJURY WAS REPORTED AND NO TREATMENT WAS RECEIVED. QUALITY CONTROL TESTING HAD NOT BEEN PERFORMED ON THE SYSTEM. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR INSULIN (TYPE UNK), 20 UNITS - ONCE DAILY, 6 MTHS| (UNK) HEART MEDICATION 25 MG - TWICE DAILY