BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLER

    MDR report key: 206651 · Received January 13, 1999

    Report

    Report Number
    2250051-1998-00640
    Event Type
    Malfunction
    Date Received
    January 13, 1999
    Date of Event
    December 18, 1998
    Report Date
    December 21, 1998
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HEPATITIS SURFACE ANTIGEN ASSAY, A SAMPLE BARCODE IN POSITION A11 WAS MISREAD. SUMMIT SAMPLE HANDLER, WAS IN USE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other