BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLER

    MDR report key: 181817 · Received August 7, 1998

    Report

    Report Number
    2250051-1998-00529
    Event Type
    Malfunction
    Date Received
    August 7, 1998
    Date of Event
    July 3, 1998
    Report Date
    July 29, 1998
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN HTLV I/II ASSAY, A SAMPLE BARCODE IN POSITION A12 WAS MISREAD. THE CUSTOMER ALSO REPORTED THAT DURING A HEPATITIS CORE ASSAY A SAMPLE BARCODE IN POSITION A11 WAS MISREAD. SUMMIT SAMPLE HANDLER WAS IN USE DURING BOTH MISREADS. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC COMPLAINT NUMBER 98-03033-07.

    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