BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3843993 · Received June 2, 2014

    Report

    Report Number
    1056600-2014-00031
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 5-23-2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND VERIFIED THE GRIPPER ADJUSTMENT. THE FE PERFORMED A READER CAMERA ADJUSTMENT AND GENERATED A NEW REFERENCE IMAGE. WADDIAG SUCCESSFULLY PASSED. THE FE VERIFIED CARDS PICTURES, ALL WERE ACCEPTABLE. THE CUSTOMER RAN QC AND ACCEPTED RESULTS. THE CUSTOMER ALSO RAN THE SAME SAMPLE MANUALLY AND USING THE PROVUE. THE CUSTOMER ACCEPTED REPAIR. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PROVUE GAVE A NEGATIVE RESULT FOR A SAMPLE THAT WAS POSITIVE VISUALLY AND IN MANUAL GEL. NO ERRONEOUS RESULTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321608 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1