BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181017 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07225
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS .
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 78 MG/DL AND 187 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. THE CUSTOMER DOES NOT HAVE THE STRIPS USED DURING THE EVENT. THE SUSPECTED PRODUCT IS UNAVAILABLE FOR RETURN; 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 .

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR GLYBURIDE| METFORMN