BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2900086 · Received January 7, 2013

    Report

    Report Number
    1056600-2013-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 7, 2013
    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 DILUENTS AND THE LISTED 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 THE GEL CARDS INCORRECTLY BY REVIEWING RANDOM .TIF IMAGES. ON (B)(4) 2013 AN OCD FIELD SERVICE ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND THE CARDS TO BE SLIGHTLY CROOKED AND THE RIGHT REAR GRIPPER PIN TO BE SLIGHTLY BINDING. THE FE REPLACED ALL FOUR GRIPPER PINS AND THE GRIPPER PIN SPRINGS. THE FE PERFORMED ALL GRIPPER ADJUSTMENTS. THE FE VERIFIED PROPER OPERATION BY PERFORMING THE DIAGNOSTICS CARD READ PROCEDURE 3 TIMES WITHOUT ERROR. ALL IMAGES WERE AS EXPECTED. QC PERFORMED AND ACCEPTED BY THE CUSTOMER. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS 2 SEPARATE EVENTS OF FALSE POSITIVE REACTIONS TO THE ANTI-A MICRO WELL IN THE MTS ABD/ABD GEL CARD ISSUED BY THE PROVUE (1 EVENT WITH A DONOR SAMPLE AND 1 EVENT WITH A QC SAMPLE). THE EVENT INVOLVING THE DONOR SAMPLE IS REPORTABLE. NO INCORRECT RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8368 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1