BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 272331 · Received March 31, 2000

    Report

    Report Number
    2250051-1999-00919
    Event Type
    Malfunction
    Date Received
    March 31, 2000
    Date of Event
    November 20, 1999
    Report Date
    March 9, 2000
    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 WHILE RUNNING A HIV-1 P24 ANTIGEN ASSAY, SUMMIT SAMPLE HANDLER, DID NOT PIPETTE LYSE BUFFER IN WELL POSITION B2 AND C2 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 99-05433-11. THIS REPORT IS BEYOND THE 30-DAY REPORTING REQUIREMENT. INFO BECAME AVAILABLE ON 3/9/2000 INDICATING THAT ORIGINAL EVENT WAS MDR REPORTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other