BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM BASE

    MDR report key: 1052260 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03772
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 6, 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

    REPORTER ALLEGED FINDING THE PLASTIC MELTED ON THE TOP CORNER OF THE INFORM BASE UNIT. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF SUSPECT DEVICE AND REPLACEMENT PRODUCT 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