BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1051727 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04113
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    March 15, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINS: 58 MG/DL, 253 MG/DL AND 306 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 CORP. 550051

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ACIDOPHILUS| UNK ORAL DIABETES MEDS| MORPHINE| UNK FAST-ACTING INSULIN - 1 DAY| LANTUS 10 UNITS - 3 WEEKS| PRILOSEC| ALBUTEROL