BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3232418 · Received July 18, 2013

    Report

    Report Number
    1056600-2013-00039
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 17, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED TEMPERATURE TESTING ON THE TWO PROVUES IN THE CUSTOMER'S FACILITY. THE FE ALSO PERFORMED TEMPERATURE TESTING ON THE MANUAL GEL STATION INCUBATOR. ALL INCUBATORS WERE WITHIN 1 DEGREE OF EACH OTHER AT TESTING. THE FE THEN FORWARDED LOG FILES AND IMAGES OF THE TESTING AND CARDS USED TO 2ND LEVEL SUPPORT. THE INSTRUMENT IS READING THE CARDS APPROPRIATELY. THE FE INFORMED THE BLOOD BANK SUPERVISOR OF THIS INFORMATION AND THEY ACCEPTED THE ANALYZER AS FULLY OPERATIONAL. ALL TESTING, REPAIRS AND ADJUSTMENTS WERE MADE PER THE SERVICE MANUAL. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES PANEL ID TESTING WITH DONOR SAMPLES WERE NEGATIVE USING THE ORTHO PROVUE BUT POSITIVE IN MANUAL GEL. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334637 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1