BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2853297 · Received November 30, 2012

    Report

    Report Number
    1056600-2012-00060
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTS CONFIRMED THAT THE MTS DILUENT AND THE LISTED ABD GEL CARDS ALL HAVE NORMAL APPEARANCE AND HAVE BEEN STORED ACCORDINGLY. ALL FOILS TO THE GEL CARDS CONFIRMED TO BE SEALED. CTS GUIDED THE CUSTOMER INTO THE LOG FILES AND CONFIRMED THE GRIPPER TO BE HOLDING GEL CARDS CORRECTLY AND STRAIGHT BY REVIEWING RANDOM .TIF IMAGES. CTS DISCUSSED MULTIPLE CAUSES OF A POTENTIAL MISREAD BY THE PROVUE GEL CAMERA INCLUDING HEMOLYSIS AND POTENTIAL INTERFERENCE TO THE GEL CAMERA. THE CUSTOMER INDICATES THEIR CONFIDENT THAT THE REPORTED CONCERNS WERE ISOLATED EVENTS (MULTIPLE SUCCESSFUL BATCHES TO QC, PATIENTS, AND DONORS ALL SUCCESSFUL WITHOUT ANY DISCREPANCIES). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSE POSITIVE REACTIONS TO THE ANTI-A MICROWELL IN THE MTS ABD/ABD GEL CARD THAT WAS CONFIRMED TO BE TYPE "O" BLOOD GROUP WITH REPEAT TESTING IN THE MANUAL GEL METHOD. NO INCORRECT 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

    Patients

    Seq Age Sex Outcome Treatment
    1