BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE TEST STRIPS

    MDR report key: 854465 · Received October 10, 2006

    Report

    Report Number
    1823260-2006-05740
    Event Type
    Malfunction
    Date Received
    October 10, 2006
    Date of Event
    September 21, 2006
    Report Date
    September 21, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMFORT CURVE TEST STRIPS: 549310, 2030373, 12/31/07.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 70 MG/DL WITH ADVANTAGE TEST STRIPS AND 119 MG/DL WITH COMFORT CURVE TEST STRIPS ON THE SAME DEVICE WITHIN 5 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED AND NO TREATMENT RECEIVED. NO QUALITY CONTROLS WERE USED ON EITHER VIAL. REQUESTED RETURN OF SUSPECT VIALS AND REPLACEMENTS WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS * 522753

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR METFORMIN| ACTOS| ACCU-CHEK ADVANTAGE| LISPRO| GLIPIZIDE