BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 4202078 · Received October 27, 2014

    Report

    Report Number
    1056600-2014-00071
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 27, 2014
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD REP PROVIDED CTS WITH A SUMMARY OF THE COMPLAINT AND IMAGES OFF OF THE PROVUE, ORTHO VISION AND MANUAL GEL. UPON INSPECTION OF THE IMAGES PROVIDED, DISTURBANCE OF THE CELL BUTTON WAS NOTED WITH THE VISION RESULTS BUT NONE OFF OF THE TESTING OF THE PROVUE. DATA COLLECTED AND DOCUMENTATION INDICATES THAT THE MATRIX OF THE FLUID BEING TESTED APPEARS TO BE THE CAUSE OF THE CONCERN. LISTED PROVUE HAS BEEN CONFIRMED TO BE USED FOR INTERNAL VALIDATION TESTING AT THE CUSTOMER'S SITE AND IS NOT BEING USED FOR PATIENT RELEASE RESULTS. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS SAMPLE RELATED.

    Description of Event or Problem · 1

    OCD REP CONTACTING CTS TO REPORT OF A FALSE NEGATIVE REACTION ON THE PROVUE AND BY THE MANUAL GEL METHOD FOR A SAMPLE KNOWN TO CONTAIN ANTI-D AND ANTI-E IN THE PLASMA, WHEREAS THE ORTHO VISION EXHIBITED A 1+ REACTIONS. DESCRIBED TESTING IS BEING PERFORMED IN SUPPORT OF THE VISION METHOD COMPARISON VALIDATION TESTING FOR THE MTS ANTI-IGG GEL WITH THE (B)(4) RESOLVE PANEL A. NO INCORRECT OR ERRONEOUS RESULT HAVE BEEN REPORTED AS A RESULT OF THE REPORTED CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684327 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1