BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 97224 · Received June 5, 1997

    Report

    Report Number
    2250051-1997-00039
    Event Type
    Other
    Date Received
    June 5, 1997
    Date of Event
    May 8, 1997
    Report Date
    June 5, 1997
    Manufacturer
    ORTHO DIAGNOSTIC SYSTEMS, INC.
    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, USING SUMMIT SAMPLE HANDLER 3 WELLS DID NOT HAVE SPECIMEN DILUENT AND SAMPLE ADDED. NO ERROR MESSAGE WAS GENERATED. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRSPONDS TO ORTHO DIAGNOSTIC SYSTEMS COMPLAINT NUMBER 97-02624-05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT SAMPLE HANDLING SYSTEM SAMPLE HANDLER JTC ORTHO DIAGNOSTIC SYSTEMS, INC. 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other