BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3781041 · Received April 30, 2014

    Report

    Report Number
    1056600-2014-00025
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON (B)(4) 2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CHECKED THE SYRINGE FOR LEAKING, CHECKED THE WASH BLOCK FOR CRACKS, CHECKED ALL BOTTLE CAPS AND FITTINGS, CLEANED HANDLER AND REAGENT CAROUSELS, AND PERFORMED ALL WAD DIAGNOSTICS TESTS. ALL TESTS PASSED. THE INSTRUMENT IS OPERATING AS EXPECTED. NO REPAIRS NEEDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSE NEGATIVE REACTIONS WITH 4 PATIENT SAMPLES WHEN USING THE ORTHO PROVUE IN THE ABO FORWARD TEST. NO ERRONEOUS RESULTS WERE REPORTED. THIS IS INCIDENT 3 OF 4. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259767 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1