BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1003476 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01778
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE INFORM SYSTEM WITH RESULTS OF HI (>600MG/DL) AND 35MG/DL. CALLER REPORTS ROUTINE QC TESTING APPEARS TO HAVE BEEN PERFORMED AND ALL RESULTS WERE PASS. NO PT INFO WAS PROVIDED. A REQUEST WAS MADE FOR RETURN OF THE 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 - LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK