BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181012 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07222
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED AN 80MG/DL AND 230MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE CUSTOMER STATES HE OBTAINED AN ADDITIONAL COMPARISON WITH BLOOD GLUCOSE RESULTS 56MG/DL AND 263MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. THE CUSTOMER FELT SHAKY, SWEATY AND GENERALLY NOT WELL WITH EACH SET OF COMPARISONS. THE CUSTOMER TREATED HIMSELF BY DRINKING ORANGE JUICE AFTER THE 56MG/DL AND 263MG/DL RESULTS. HE FELT BETTER AFTER TREATMENT. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED WITH THE 80MG/DL AND 230MG/DL BLOOD GLUCOSE COMPARISON. 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 CORP. 550751

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR METFORMIN- 5 YRS| HUMALOG - 2 WEEKS