BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLAB AT PLUS 2

    MDR report key: 436388 · Received January 3, 2003

    Report

    Report Number
    2915796-2003-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2003
    Date of Event
    December 3, 2002
    Report Date
    January 2, 2003
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAMILTON CO WAS INFORMED OF AN EVENT THAT OCCURRED IN 2002, IN WHICH THE HAMILTON MICROBLAB AT +2 INSTRUMENT REPORTEDLY TRANSPOSED THE LOCATIONS OF BARCODES FOR SAMPLE IDENTIFICATION. NO DEATH OR INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLAB AT PLUS 2 MICROTITER DILUTING/DISPENSING JTC HAMILTON BONADUZ AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other