BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 112280 · Received August 8, 1997

    Report

    Report Number
    2250051-1997-00057
    Event Type
    Other
    Date Received
    August 8, 1997
    Date of Event
    July 17, 1997
    Report Date
    July 31, 1997
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS CORE ASSAY THE SUMMIT SAMPLE HANDLER FAILED TO PIPETTE SAMPLE OR DILUENT INTO ROW A AND POSITION B-1. 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