BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022634 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02863
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 31, 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

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 549642, EXPIRATION DATE 06/30/2008). REF MEDWATCH REPORT WITH PT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 232 MG/DL ON ADVANTAGE SYSTEM 1 AND 116 MG/DL AND 109 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE 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 549642

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NOVOCOR 70/30 10UNITS IN PM| NOVOCOR 70/30 12UNITS IN AM