BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM BASE

    MDR report key: 1052048 · Received May 21, 2008

    Report

    Report Number
    1823260-2008-04195
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BLACKENED CONTACTS ON THE INFORM SYSTEM. THE EDGES OF THE PLASTIC CONNECTION THAT CONTAIN THE CONTACTS ALSO APPEAR TO BE PARTIALLY 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