BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2062752 · Received April 19, 2011

    Report

    Report Number
    1056600-2011-00031
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 19, 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 CHECKED THE TEMPERATURE, CENTRIFUGE SPEED, TIMING, PRESSURE, AND VACUUM. THE FE REPEATED THE READER ADJUSTMENTS AND THE CAMERA SETTING. THE CUSTOMER RAN AND VERIFIED QC WAS FINE. THE PROVUE IS OPERATING AS EXPECTED AND WITHIN SPECIFICATION. THE INSTRUMENT IS OPERATING AS EXPECTED. NO REPAIRS NEEDED. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE PROVUE GAVE A NEGATIVE RESULT FOR AN ANTIBODY THAT WAS DETECTED IN THE MANUAL GEL METHOD. 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 2.15

    Patients

    Seq Age Sex Outcome Treatment
    1