BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761191 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06071
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 13, 2007
    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

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS IN THE 300S-400S MG/DL BACK TO BACK WITH A RESULT IN THE 90S-118 MG/DL WHEN TESTING WAS PERFORMED ON THE ADVANTAGE SYSTEM. REPORTER STATED HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549605

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR