BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2853009 · Received November 30, 2012

    Report

    Report Number
    1056600-2012-00057
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 AN OCD FIELD ENGINEER (FE) WENT TO THE CUSTOMER SITE AND CHECKED ALL CAMERA ADJUSTMENTS FOR THE FALSE NEGATIVE AND CAMERAS LOOKED GOOD NO ADJUSTMENT NEEDED. THE FE ALSO DID A PROBE BOTTOM CALIBRATION. THERE WAS NO CHANGE IN CALIBRATION (CALIBRATION OK). THE CUSTOMER RAN CONTROLS AND ALL CONTROLS RAN AS EXPECTED. NO REPAIRS NEEDED, INSTRUMENT RUNNING AS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ON (B)(6) 2012 THE ORTHO PROVUE REPORTED A FALSE NEGATIVE ANTIBODY SCREEN RESULT FOR A SAMPLE THAT WERE POSITIVE IN MANUAL GEL. INCORRECT RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT. CORRECTED REPORTS HAVE BEEN ISSUED FOR THE AFFECTED SAMPLES. THERE WAS NO TRANSFUSION REACTION OR HARM TO ANY PATIENT.

    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