BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM BASE

    MDR report key: 1181699 · Received September 30, 2008

    Report

    Report Number
    1823260-2008-07252
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED CONTACT PINS 3,4 'SCORCHED', EVIDENCE OF MELTED PLASTIC ON THE INTERCONNECTOR OF THE INFORM SYSTEM BASE UNIT. CUSTOMER REPORTED NO PATIENT/STAFF AFFECTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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