BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 4152032 · Received October 8, 2014

    Report

    Report Number
    1056600-2014-00063
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 8, 2014
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA COLLECTED AND DOCUMENTATION INDICATES THAT THE MATRIX OF THE FLUID BEING TESTED APPEARS TO BE THE CAUSE OF THE CONCERN. THE CONCERN IS ISOLATED TO THE ONE TEST OF THE PATIENT SAMPLE THAT CANNOT BE DUPLICATED. 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 WITH A SAMPLE KNOWN TO CONTAIN ANTI-S IN THE PLASMA AGAINST CELL#3 AND 4 TO THE 0.8% RESOLVE PANEL C LOT# VRC196 WHEN TESTED ON THE PROVUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632357 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ

    Patients

    Seq Age Sex Outcome Treatment
    1