BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 137926 · Received December 11, 1997

    Report

    Report Number
    2250051-1997-00121
    Event Type
    Other
    Date Received
    December 11, 1997
    Date of Event
    November 21, 1997
    Report Date
    December 8, 1997
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING AN ANTIBODY SCREENING ASSAY, SUMMIT SAMPLE HANDLER DID NOT DISPENSE THE FULL AMNOUNT OF LIQUID IN POSITION 6 OF ROWS A THROUGH H. NO ERROR MESSAGE WAS GIVEN. AN ORTHO FIELD SERVICE 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