BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 4120936 · Received September 26, 2014

    Report

    Report Number
    1056600-2014-00057
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE. FE REPLACED THE SYRINGE, PROBE, AND TUBING FROM THE CLOT DETECTOR BOARD TO THE PROBE. PERFORMED SPEED AND TIMING VERIFICATION ON THE CENTRIFUGE, WHICH PASSED. PERFORMED 24 AND 37 DEGREE, PERFORMED TEMPERATURE CHECK OF BOTH INCUBATORS, WHICH PASSED. POST REPAIR, FE RAN SUCCESSFUL DIAGNOSTICS TESTS FOR TEMPERATURE, REGULATION, CENTRIFUGING, FLUID CIRCUIT, AND PIPETTING. CUSTOMER RAN THE SPECIMEN IN QUESTION FOR DAT AND THE RESULT WAS 1+ AS EXPECTED. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE DAT ON PROVUE SERIAL (B)(4) USING MTS IGG GEL CARDS. CUSTOMER REPEATED THE DAT TEST ON A SECOND PROVUE, RESULTS FROM THE REPEAT TESTING WERE WEAK 1+ REACTION. THE SAMPLE WAS ALSO TESTED MANUALLY. THE MANUAL DAT HAD A WEAK 1+ REACTION. SERVICE WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601950 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1