BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1905710 · Received November 23, 2010

    Report

    Report Number
    1056600-2010-00133
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    August 5, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD INITIATED A FAILURE INVESTIGATION UNDER QERTS #(B)(4).

    Description of Event or Problem · 1

    ORTHO PROVUE SOFTWARE VERSION 3.1:THE ISSUE WAS DISCOVERED INTERNALLY AND FOLLOWING SCENARIO OCCURRED:- WHILE PERFORMING IAT XM TESTING, THE SYSTEM FAILED TO DISPENSE PLASMA AFTER CLOT DETECTION (MAQERRCODE4 ). ALTHOUGH NO SAMPLE WAS DISPENSED, NO ERROR CODE WAS POSTED AND TEST RESULTS WERE REPORTED BY THE SYSTEM.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1