BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLER

    MDR report key: 179259 · Received July 27, 1998

    Report

    Report Number
    2250051-1998-00523
    Event Type
    Malfunction
    Date Received
    July 27, 1998
    Date of Event
    June 22, 1998
    Report Date
    July 14, 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 HIV-1 P24 ASSAY IN SAMPLE BARCODE IN POSITION H4 WAS MISREAD. SUMMIT SAMPLE HANDLER WAS IN USE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. AN ORTHO FIELD SERVICE ENGINEERS WAS DISPATCHED. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC COMPLAINT NUMBER 98-02801-06.

    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