BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1133553 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06379
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS TESTING ON THE METER WITH A RESULT OF 313 MG/DL AND THEN RETESTED USING A DIFFERENT VIA OF STRIPS FROM THE SAME LOT NUMBER WITH A RESULT OF 109 MG/DL WHILE USING THE ADVANTAGE SYSTEM. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    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 550080

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HUMALOG - 8 YEARS| HUMALOG 75/25 - 8 YEARS| LANTUS - 1 YEAR