BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2241621 · Received September 9, 2011

    Report

    Report Number
    1056600-2011-00079
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 9, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED A CAMERA ADJUSTMENT. THE FE ALSO SET THE BRIGHTNESS AT 116 AND GENERATED A NEW REFERENCE IMAGE. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION.(B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ORTHO PROVUE GEL CAMERA READ THE FIRST MICROWELL OF AN ABO FORWARD GROUPING TEST AS 1+ WHEN VISUAL INSPECTION WAS NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1