BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 261429 · Received February 1, 2000

    Report

    Report Number
    2250051-2000-00104
    Event Type
    Malfunction
    Date Received
    February 1, 2000
    Date of Event
    January 6, 2000
    Report Date
    January 20, 2000
    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

    CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS SURFACE ANTIGEN ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE SAMPLE OR DILUENT INTO WELL POSITION C4 AND DID NOT GIVE AN ERROR MESSAGE. A FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC COMPLAINT NUMBER 00-00251-01.

    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