BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 838059 · Received October 25, 2006

    Report

    Report Number
    1823260-2006-06143
    Event Type
    Malfunction
    Date Received
    October 25, 2006
    Date of Event
    August 8, 2006
    Report Date
    October 4, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS FROM 800->900 MG/DL ON THE DEVICE. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. DEVICE NUMERIC READING RANGE IS 10 MG/DL TO 600 MG/DL. RESULTS >600 MG/DL WERE NOT FOUND IN THE DEVICE MEMORY. REQUESTED RETURN OF SUSPECT DEVICE AND 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 NBW ROCHE DIAGNOSTICS * 548683

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR ACCU-CHEK ADVANTAGE