BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1991877 · Received February 15, 2011

    Report

    Report Number
    1056600-2011-00012
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REFUSED SERVICE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES A SAMPLE CONTAINING ANTI-E WAS CROSSMATCHED AGAINST E+ DONOR UNITS AND THE PROVUE RESULTED THE UNITS AS COMPATIBLE NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED.

    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