BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM BASE

    MDR report key: 1002656 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01375
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 17, 2007
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    BASED ON INVESTIGATION PERFORMED BY MFR'S DOMESTIC EVAL UNIT ON PRODUCT RETURNED BY THE CUSTOMER, THE INFORM METER WAS FOUND TO HAVE MELTING AND BURNING CONSISTENT WITH AN ELECTRICAL SHORT. NO SERIOUS ADVERSE EVENT WAS REPORTED IN RELATION TO THE PRODUCT.

    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