BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1182643 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05666
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    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

    REPORTER ALLEGED SEGMENTS WERE MISSING FROM THE DISPLAY OF THE COMPACT PLUS SYSTEM. REPORTER IS FROM THE MANUFACTURER'S EVALUATIONS DEPT, AND DISCOVERED THE ALLEGED ISSUE AFTER THE DEVICE WAS RETURNED. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. THE SUSPECT DEVICE WAS RETURNED AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK