BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SAMPLE PROCESSOR

    MDR report key: 1628354 · Received March 11, 2010

    Report

    Report Number
    2250051-2010-00056
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 11, 2010
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND DETERMINED THE SYRINGE WAS LEAKING. THE FSE REPLACED THE LEAKING SYRINGE AND VERIFIED THE REPAIRS. INSTRUMENT IS WORKING AS EXPECTED FOLLOWING REPAIRS.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED TRACES OF CONJUGATE BETWEEN WELLS DURING RUN OF BIO-RAD HBC ASSAY. NO ERROR WAS GENERATED. NO ERRONEOUS RESULTS WERE REPORTED.NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SAMPLE PROCESSOR ELISA MICROWELL PLATE PROCESSOR JTC HAMILTON BONADUZ AG 936480

    Patients

    Seq Age Sex Outcome Treatment
    1