BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM BASE

    MDR report key: 1052263 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03780
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    Z-1060-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BLACKENED CONNECTOR PINS ON THE INFORM SYSTEM. CUSTOMER STATES THE METER PLASTIC APPEARS TO BE MELTED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK