BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM METER

    MDR report key: 1040951 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03712
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 9, 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

    UPON INVESTIGATION IN 2008, MFR'S DOMESTIC EVALUATIONS LAB FOUND INFORM ELECTRICAL CONTACT PINS 3 AND 4 MELTED/BURNED. NO ADVERSE EVENT REPORTED.

    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