BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 8640160 · Received May 24, 2019

    Report

    Report Number
    1056600-2019-00021
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 17, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2019 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND VERIFIED READER CAMERA ALIGNMENT. FE REVISITED READER CAMERA OPTICS. BRIGHT CAM 0: 120, RANGE IS 101 TO 128. FE RAN A DIAGNOSTICS TESTS SUCCESSFULLY. NO ERRONEOUS RESULTS REPORTED. NO TRANSFUSION OR TREATMENT WAS DELAYED BECAUSE OF THIS INCIDENT. THE ROOT-CAUSE COULD NOT BE CONFIRMED ALTHOUGH THE MOST PROBABLE ROOT CAUSE IS ASSOCIATED WITH AN ANTI-E ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED.

    Description of Event or Problem · 1

    THE CUSTOMER IS REPORTING FALSE NEGATIVE REACTIONS ON THE PROVUE FOR THE ANTIBODY SCREEN TEST WITH A PATIENT KNOWN TO BE POSITIVE FOR ANTIBODIES. CUSTOMER DID A PANEL AND CONFIRMED AN ANTI-E AND NON SPECIFIC AUTO-ANTIBODY. CUSTOMER USED IGG GEL CARDS LOT 013019001-12, EXP: NOV 25 2019 WITH 0.8% SURGISCREEN LOT VSS087. CUSTOMER SAW A WEAK REACTION ON CELL 2 ON THE CARD WHEN BROUGHT IN THE SERVICE RACK BECAUSE IT WAS PARTIALLY USED. ERRONEOUS RESULT WAS NOT REPORTED. NO ISSUE REPORTED WITH ALBA-Q CHECK QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436137 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1