BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 145897 · Received January 23, 1998

    Report

    Report Number
    2250051-1998-00007
    Event Type
    Other
    Date Received
    January 23, 1998
    Date of Event
    January 6, 1998
    Report Date
    January 23, 1998
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HIV ANTIBODY ASSAY, SUMMIT SAMPLE HANDLER, FAILED TO PIPETTE REAGENT/SAMPLE IN ROWS A-H WELL POSITIONS 10, 11, 12 AND NO ERROR MESSAGE WAS GENERATED. AN ORTHO FIELD SVC 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