BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM

    MDR report key: 255554 · Received December 16, 1999

    Report

    Report Number
    2250051-1999-00891
    Event Type
    Malfunction
    Date Received
    December 16, 1999
    Date of Event
    June 29, 1999
    Report Date
    June 30, 1999
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING AN HCV ASSAY, SUMMIT SAMPLE HANDLER, SCANNED ROW B TWICE, PIPETTED ROW B INTO ROW E AND DID NOT GIVE AN ERROR MESSAGE. A 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 99-02801-06. THIS REPORT IS BEYOND THE 30-DAY REPORTING REQUIREMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other