BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3676453 · Received March 13, 2014

    Report

    Report Number
    1056600-2014-00014
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND REPLACED THE SYRINGE. THE CUSTOMER RAN AND ACCEPTED CONTROLS. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS 1ST OF 2 EVENTS OF FALSE NEGATIVE RESULTS TO DATE (IGG) TESTING OF CORD BLOOD SAMPLES ON THE ORTHO PROVUE THAT WAS POSITIVE ON AN ALTERNATIVE PROVUE. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149850 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1