BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 85209 · Received April 15, 1997

    Report

    Report Number
    2250051-1997-00020
    Event Type
    Other
    Date Received
    April 15, 1997
    Date of Event
    March 31, 1997
    Report Date
    April 15, 1997
    Manufacturer
    HAMILTON BONADUZ
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING A HEPATITIS C ASSAY THE SAMPLE HANDLER, SERIAL NUMBER 1934, FAILED TO ASPI12199301996 IN TWO POSITIONS. NO ERROR MESSAGE WAS GIVEN. CO FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO CO COMPLAINT NUMBER 97-01824-04.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other