BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040936 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03730
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 4, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    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 3364 MG/DL AND 126 MG/DL. L1 AND L2 QUALITY CONTROLS WERE OUT OF RANGE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 549822

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR