BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1336766 · Received February 23, 2009

    Report

    Report Number
    1823260-2009-01419
    Event Type
    Malfunction
    Date Received
    February 23, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 23, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 30 MG/DL AND 100 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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. 550079

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GLYBURIDE 5 MG/5/DAY - 1 YEAR| SYNTHROID 25 MG/DAY - 1.5 YEAR