BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLER

    MDR report key: 237103 · Received August 18, 1999

    Report

    Report Number
    2250051-1999-00817
    Event Type
    Malfunction
    Date Received
    August 18, 1999
    Date of Event
    May 12, 1999
    Report Date
    May 12, 1999
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING AN HTLV I/II ASSAY, THE FOLLOWING SAMPLE BARCODES WERE READ INCORRECTLY: 1. "022 GW59906" WAS READ AS "022 KY32083." 2. "022 GW59907" WAS READ AS "022 KY32084." 3. "022 GW59908" WAS READ AS "022 KY32085." 4. "022 GW59909" WAS READ AS "022 KY22909." SUMMIT SAMPLE HANDLER WAS IN USE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. THIS REPORT IS BEING ISSUED BEYOND THE 3O-DAY REPORTING REQUIREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLER SAMPLE HANDLER JTC HAMILTON BONADUZ AG 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other