BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033286 · Received April 18, 2008

    Report

    Report Number
    1823260-2008-03370
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT HE EXPERIENCED AN EVENT WHERE HE HAD NO STRENGTH AND COULD NOT GET UP OFF THE FLOOR. HIS BLOOD GLUCOSE RESULT WAS 131 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM IN COMPARISON TO THE PROFESSIONAL METER BLOOD GLUCOSE RESULT OF 54 MG/DL. THE BLOOD GLUCOSE RESULTS WERE OBTAINED WITHIN A 10 MIN TIMEFRAME. THE PARAMEDICS TREATED THE REPORTER WITH GLUCOSE (IV). HE ALSO DRANK A COKE AND FELT BETTER WITHIN 5-10 MINS. NEW SYSTEM SENT AND RETURN REQUESTED.

    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 550089

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LISINOPRIL| OMEPRAZOLE| SIMVASTATIN| CARVEDILOL| BAYER ASPIRIN| LEVOTHYROXINE| LEVOTHYOXINE| GEMFIBROZIL| GLYBURIDE