BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 218286 · Received April 6, 1999

    Report

    Report Number
    2250051-1999-00733
    Event Type
    Malfunction
    Date Received
    April 6, 1999
    Date of Event
    March 15, 1999
    Report Date
    March 16, 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

    THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS SURFACE ANTIGEN ASSAY, SUMMIT SAMPLE HANDLER, DID NOT PIPPETTE SAMPLE OR DILUENT IN WELL POSITION A10 AND DID NOT GIVE AN ERROR MESSAGE. 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