BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 281647 · Received June 7, 2000

    Report

    Report Number
    2250051-2000-00164
    Event Type
    Malfunction
    Date Received
    June 7, 2000
    Date of Event
    April 20, 2000
    Report Date
    May 4, 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

    THE CUSTOMER REPORTED THAT WHILE RUNNING AN HEPATITIS C VIRUS ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE THE CORRECT AMOUNT OF SAMPLE AND/OR DILUENT AND DID NOT GIVE AN ERROR MESSAGE. AN ORTHO FIELD SVC ENGINEER WAS DISPATCHED, AND COMPLAINT WAS CONFIRMED. FSE REPLACED TIPS, PLUNGER CLAMPS AND "LLD" SPRINGS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER 00-02207-05.

    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