BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3243319 · Received July 23, 2013

    Report

    Report Number
    1056600-2013-00042
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 23, 2013
    Report Date
    July 23, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CHECKED THE READER CAMERA ALIGNMENTS AND FOUND THEM WITHIN SPECIFICATIONS. THE FE CLEANED THE CAMERA DIFFUSER PLATE, LAMPS, AND CAMERA LENS THOROUGHLY. THE FE PERFORMED THE READER CAMERA FINE ADJUSTMENTS AND RECEIVED A LIGHT READING OF 115 (WELL WITHIN SPECIFICATIONS OF 101-128). THE FE ALSO CREATED A NEW REFERENCE IMAGE. THE FE RAN WAD DIAGNOSTICS READING / PIPETTING SIMULATION SUCCESSFULLY. THE CUSTOMER RAN, VERIFIED, AND ACCEPTED QC. THE CUSTOMER RERAN THE IAT CROSSMATCH WITH THE SAME CAP SAMPLES AND RESULTED AS EXPECTED. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT DURING CAP PROFICIENCY TESTING THE PROVUE GAVE A FALSE NEGATIVE RESULT FOR A CROSSMATCH IAT TEST WITH A SAMPLE THAT HAD ANTI-C. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342502 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1