BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3913119 · Received July 3, 2014

    Report

    Report Number
    1056600-2014-00035
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON 6-18-2014, AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE TO INVESTIGATE THE ISSUE. FE CHECKED THE CARD AND CARD PICTURE, HE CONFIRMED A WEAKLY POSITIVE RESULT FOR BOTH. FE CLEANED OPTICS, CHECKED GRIPPER FINE ADJUSTMENT, PERFORMED ALL READER CAMERA ADJUSTMENTS AND GENERATED A NEW REFERENCE IMAGE. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROVUE ISSUED A NEGATIVE RESULT WITH CELL I OF THE SELECTOGEN CELLS TO A VISUALLY WEAKLY POSITIVE RESULT. NO ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389146 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1