BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM

    MDR report key: 1011707 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02280
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INITIALLY ALLEGED FINDING PINS BLACKENED ON THE INFORM METER. THE MFR'S EVAL DEPT. CONFIRMED THAT THERE WAS MELTING AND BURNING OF THE THIRD AND FOURTH PINS. NO ADVERSE EVENT REPORTED. THE DEVICE WAS RETURNED, EVALUATED, AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM BLOOD GLUCOSE MONITORING DEVICE- NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEDICAL PRODUCTS UNK