BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1082548 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05711
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 160 MG/DL AND 87 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM WITHIN A TEN MINUTE TIMEFRAME. HE FELT HYPOGLYCEMIC. THE CUSTOMER STATES THAT HE DID NOT TAKE ANY ADDITIONAL MEDICATIONS OR TAKE ACTIONS BASED ON RESULTS. HOWEVER, HE ALSO STATED THAT HE ATE FOOD AND FELT BETTER AFTERWARD. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER 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 550539

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR LANTUS - 6 YEARS| ZETIA - 6 YEARS| CHOLESTYRAMINE - 6 YEARS| WELCHOL - 6 YEARS| HUMALOG - 6 YEARS