BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 6282377 · Received January 27, 2017

    Report

    Report Number
    1056600-2017-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 27, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED A CHECK OF THE PROVUE AND FOUND THAT THE WASH STATION WAS LEAKING. THE FE REPLACED THE WASH STATION AND PROBE. THE FE PERFORMED ALL REQUIRED ADJUSTMENTS. THE READER CAMERA VALUE IS 114 WHICH IS WITHIN SPECIFICATION (101-128). THE FE CREATED A NEW REFERENCE IMAGE. THE CUSTOMER RAN AND ACCEPTED QC. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION WITH A PATIENT SAMPLE DURING CROSSMATCH TESTING DURING CORRELATION TESTING BETWEEN THE ORTHO PROVUE AND MANUAL GEL METHOD. NO INCORRECT RESULTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67761 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1