BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLER

    MDR report key: 175877 · Received July 1, 1998

    Report

    Report Number
    2250051-1998-00509
    Event Type
    Malfunction
    Date Received
    July 1, 1998
    Date of Event
    June 8, 1998
    Report Date
    June 19, 1998
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HCV ASSAY, THE SAMPLE ID IN POSITION A8 WAS MISREAD. THE CUSTOMER ALSO REPORTED THAT DURING A HEPATITIS CORE ASSAY, THE SAMPLE ID IN POSITION A7 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. COMPLAINT NUMBER 98-02571-06.

    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