BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011810 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02302
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    March 8, 2007
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE RESULT OF HI (GREATER THAN 600 MG/DL) AND WITHIN 10 MINS GLUCOSE MEASURED IN THE 30S MG/DL ON THE ADVANTAGE SYSTEM. REPORTER STATED SHE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AT THE TIME AND PASSED OUT. REPORTER INDICATED SHE DID NOT RECEIVE ANY TREATMENT AND NO ACTIONS WERE TAKEN. 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 TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR XANAX