BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT TM SAMPLE HANDLER

    MDR report key: 262297 · Received February 8, 2000

    Report

    Report Number
    2250051-2000-00112
    Event Type
    Malfunction
    Date Received
    February 8, 2000
    Date of Event
    January 18, 2000
    Report Date
    January 28, 2000
    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

    CUSTOMER REPORTED THAT WHILE RUNNING A HEPITITIS SURFACE ANTIGEN ASSAY, A SAMPLE BARDCODE IN POSITION A12 WAS READ AS "042FS10226" INSTEAD OF "042FW65326". SUMMIT SAMPLE HANDLER WAS IN USE. NO DEATH OR SERIOUS INJURY WAS ASSOCIATYED WITH THIS EVENT. AN SERVICE ENGINEER WAS DISPATCHED. THIS REPORT CORRESPONDS TO ORHTHO-CLINICAL DIAGNOSTICS, INC. COMPLAINT NUMBER 00-00416-01.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other