BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 76725 · Received February 11, 1997

    Report

    Report Number
    2250051-1997-00007
    Event Type
    Other
    Date Received
    February 11, 1997
    Date of Event
    January 27, 1997
    Report Date
    February 11, 1997
    Manufacturer
    ORTHO DIAGNOSTIC SYSTEMS, INC.
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE RUNNING HEPITITIS CORE, HTLV, AND HCV ASSAYS, THE LAST DIGIT OF A SAMPLE BARCODE WAS DROPPED. A 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 ORTHO DIAGNOSTIC SYSTEMS, INC. 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA