BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 348928 · Received August 24, 2001

    Report

    Report Number
    2250051-2001-00520
    Event Type
    Malfunction
    Date Received
    August 24, 2001
    Date of Event
    August 10, 2001
    Report Date
    August 10, 2001
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS CORE ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE DILUENT OR CONTROL INTO WELL POSITION A5 AND NO ERROR MESSAGE WAS GENERATED. A FIELD SERVICE ENGINEER WAS DISPATCHED AND WAS ABLE TO DUPLICATE THE EVENT. FSE CLEANED BLACK SLEEVE AND TIP CLAMPS AND REPLACED PLUNGER CLAMP, LOT #1171870, IN POSITION #5. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38949 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE HANDLER JTC HAMILTON BONADUZ AG 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other