BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1983927 · Received February 10, 2011

    Report

    Report Number
    1056600-2011-00010
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND THAT THE CAMERA LENS WAS NOT SQUARE TO THE CAMERA BODY. THE FE SQUARED THE LENS AND CAMERA BODY AND SECURELY FASTENED. THE FE PERFORMED ALL READER CAMERA ADJUSTMENTS AND REPLACED THE CRACKED WASH BLOCK. THE FE ALSO PERFORMED A PM ON THE PROVUE. ALL DIAGNOSTICS TESTS WERE OK. THE CUSTOMER RAN AND VERIFIED QC. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE RESULTED WEAKLY POSITIVE ANTIBODY SCREEN RESULTS AS NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1