BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1133572 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06384
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 16, 2007
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 25 MG/DL AND 159 MG/DL WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED SYMPTOMS FOR WHICH SHE SELF-TREATED. NO ADVERSE EVENT REPORTED IN CONJUNCTION WITH THIS INCIDENT. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT SYSTEM 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR SIMVASTATIN| METFORMIN| GLIMEPIRIDE| "PAMOTLGINS"| "ANTRIPYLIN"| BACLOFEN