BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 181831 · Received August 7, 1998

    Report

    Report Number
    2250051-1998-00532
    Event Type
    Other
    Date Received
    August 7, 1998
    Date of Event
    July 8, 1998
    Report Date
    July 31, 1998
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Adverse Event
    Yes
    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 CORE ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE THE CORRECT AMOUNT OF SAMPLE IN WELL POSITIONS B8, C8, D8 AND E8 AND DID NOT GIVE AN ERROR MESSAGE. AN ORTHO 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 98-03074-07.

    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