BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1833065 · Received September 14, 2010

    Report

    Report Number
    1056600-2010-00114
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND REPLACED THE PROBE AND O RINGS ON THE WASTE BOTTLE. ALL DIAGNOSTIC PROTOCOL TESTS HAVE PASSED WITHOUT ISSUE. ALL QC HAVE PASSED WITHOUT ISSUE. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROVUE PROBE IS DRIPPING. NO ERROR MESSAGES WERE POSTED. NO ERRONEOUS RESULTS WERE POSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1