BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM METER

    MDR report key: 1082567 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05702
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED CONNECTOR PINS 3, 4, AND 5 WERE BLACKENED WHILE USING THE INFORM SYSTEM. MANUFACTURER'S INVESTIGATION UNIT CONFIRMED MELTING AND BURNING OF PINS 3 - 5. NO ADVERSE EVENT WAS 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 INFORM METER BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK