BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781081 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06495
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    June 14, 2007
    Report Date
    July 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS BACK TO BACK TESTING WITH ANOTHER PROFESSIONAL METER WHILE USING THE INFORM SYSTEM WITH RESULTS OF 473MG/DL ON THE OTHER METER AND 222MG/DL ON THIS METER (B)(4). QUALITY CONTROLS WERE RUN AND IN RANGE. NO ADVERSE EVENT REPORTED. SUSPECT PRODUCT WAS DISCARDED, A REPLACEMENT OF SUSPECT 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 549308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA INFO UNK