BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO PROVUE

    MDR report key: 1992094 · Received February 15, 2011

    Report

    Report Number
    1056600-2011-00013
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CHECKED THE FUNCTIONAL OPERATION, ALIGNMENTS, AND ADJUSTMENTS OF THE PROVUE. THE FE CLEANED THE DIFFUSER AND CREATED A NEW REFERENCE IMAGE. THE FE PERFORMED DIAGNOSTICS SUCCESSFULLY. THE CUSTOMER RAN CONTROLS SUCCESSFULLY WITHOUT ERRORS. THIS ISSUE IS BEING INVESTIGATED BY CTS-SECOND LEVEL SUPPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE PROVUE RESULTED A POSITIVE ANTIBODY SCREEN AS NEGATIVE. THE PATIENT EXPERIENCED A TRANSFUSION REACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other