BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM METER

    MDR report key: 1110228 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05148
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    April 27, 2007
    Report Date
    June 12, 2007
    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

    THE MANUFACTURER'S DOMESTIC EVALUATION DEPARTMENT CONFIRMED THERE WAS MELTING AND BURNING, ON THE CONNECTOR PINS 3 AND 4 OF THE BLOOD GLUCOSE MONITORING INFORM SYSTEM. THE ORIGINAL REPORTER INDICATED THERE WERE PINS MISSING AND GREEN OXIDATION SURROUNDING THE PINS. NO REPORT OF ANY OTHER ACTIONS OR TREATMENT. UPON RETURN OF THE REQUESTED PRODUCT, REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1