BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760879 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06032
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 77 MG/DL AND 359 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS. CUSTOMER REPORTED NO TREATMENT/ACTION BASED ON RESULTS. NO ADVERSE EVENT WAS REPORTED. 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 549716

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR GLIPIZIDE - 1 YEAR - UNKNOWN DOSAGE| ACTOS - 2 MONTHS - 30MG DAILY