BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM

    MDR report key: 1040950 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03713
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    March 10, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER, FROM THE MFR'S EVALUATIONS DEPT, ALLEGED FINDING MELTED AND BURNED PINS ON THE INFORM METER. NO ADVERSE EVENT REPORTED. THE SUSPECT DEVICE WAS RETURNED 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