BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040975 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03852
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 550502, EXPIRATION DATE 04/30/2009). REFERENCE MEDWATCH REPORT WITH PT FOR THE SUSPECT DEVICE USED IS IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 295 MG/DL ON ADVANTAGE SYSTEM 1 AND 117 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. 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 550502

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR BABY ASPIRIN 81MG 1/DAY| SIMVASTATIN 10MG 1/DAY - 11 YEARS| ATENOLOL 25MG 1/DAY - 11 YEARS| TERAZOSIN 5MG 1/DAY - 6 MONTHS| GLIPIZIDE 5MG 1/DAY - 6 MONTHS