BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 6388161 · Received March 8, 2017

    Report

    Report Number
    1056600-2017-00028
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 12, 2017
    Report Date
    March 8, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2017, AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE TO PERFORM PREVENTATIVE MAINTENANCE (PM) SERVICE. PM SERVICE PERFORMED UNDER SERVICE ORDER#(B)(4). THE FE PERFORMED PM SERVICE (XPM30 - 30 MONTH PM). PM SUCCESSFULLY COMPLETED PER CURRENT PM PROCEDURES. THE FINAL READER CAMERA BRIGHTNESS VALUE WAS 122 ( ACCEPTABLE RANGE IS 101 -128). THE CUSTOMER RAN CONTROLS. ALL CONTROLS PASSED AS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE EVENT OF THE ORTHO PROVUE GIVING A FALSE NEGATIVE ANTIBODY IDENTIFICATION RESULT THAT WAS POSITIVE IN MANUAL GEL. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171823 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1