BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1890064 · Received November 3, 2010

    Report

    Report Number
    1056600-2010-00130
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CLEANED THE LENS OF THE CAMERA AND VISOR. THE FE PERFORMED THE CARD ALIGNMENT AND RAN A REFERENCE IMAGE. THE CUSTOMER RAN QC. ALL QC WITHIN ACCEPTABLE RANGE. INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE PROVUE CAMERA RESULTED A REACTION IN THE GEL CARD AS NEGATIVE WHEN VISUAL INSPECTION OF THE GEL CARD WAS POSITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1