BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 256509 · Received December 20, 1999

    Report

    Report Number
    2250051-1999-00894
    Event Type
    Malfunction
    Date Received
    December 20, 1999
    Date of Event
    October 25, 1999
    Report Date
    October 27, 1999
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO BECAME AVAILABLE ON 12/09/1999 INDICATING THAT THIS EVENT WAS A POSSIBLE MDR. THE CUSTOMER REPORTED THAT WHILE RUNNING AN HIV-1 P24 ANTIGEN ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE THE CORRECT AMOUNT OF DILUENT INTO WELL POSITIONS B6, C6 AND D6 AND NO ERROR MESSAGE WAS GENERATED. A FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other