BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM

    MDR report key: 108248 · Received July 22, 1997

    Report

    Report Number
    2250051-1997-00052
    Event Type
    Other
    Date Received
    July 22, 1997
    Date of Event
    July 2, 1997
    Report Date
    July 18, 1997
    Manufacturer
    ORTHO DIAGNOSTIC SYSTEMS, INC.
    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 AN HIV-1 P24 ANTIGEN ASSAY, THE SUBMIT SAMPLE HANDLER, MISREAD A SAMPLE BARCODE AS "E0100017" INSTEAD OF "W33461". NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other