BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLAB AT PLUS 2

    MDR report key: 1211003 · Received July 1, 2008

    Report

    Report Number
    2250051-2008-80338
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 13, 2008
    Report Date
    July 1, 2008
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BARCODE SCANNER ON THE MICROLAB AT PLUS 2 INSTRUMENT MISREAD THE SAMPLE BARCODE. A BARCODE MISREAD COULD RESULT IN A SAMPLE FROM ONE PT BEING MISINTERPRETED FOR ANOTHER. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLAB AT PLUS 2 SAMPLE PIPETTER JTC HAMILTON BONADUZ AG 142036 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *