BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 76877 · Received March 12, 1997

    Report

    Report Number
    2250051-1997-00011
    Event Type
    Other
    Date Received
    March 12, 1997
    Date of Event
    February 26, 1997
    Report Date
    March 7, 1997
    Manufacturer
    HAMILTON BONADUZ
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS SURFACE ANTIGEN ASSAY THE DEVICE FAILED TO DISPENSE SAMPLE INTO POSITIONS 3 AND 5 IN FOWS F-H. NO ERROR MESSAGE WAS GIVEN. 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 SAMPLER HANDLER JTC HAMILTON BONADUZ 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA