BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2853253 · Received November 30, 2012

    Report

    Report Number
    1056600-2012-00059
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 THE OCD FIELD ENGINEER (FE) WENT TO THE CUSTOMER SITE AND PERFORMED ALL OPTICS ADJUSTMENTS AND CREATED A NEW REFERENCE IMAGE. REPAIRS HAVE RETURNED THE INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    AN OCD REPRESENTATIVE REPORTED DURING VALIDATION THE ORTHO PROVUE MISSED AN ANTIBODY THAT WAS DETECTED IN MANUAL GEL. ONE BATCH OF VALIDATION SAMPLES TESTED ON THE ORTHO PROVUE RESULTED "?" OR NEGATIVE AND WAS 1+ IN MANUAL GEL (ANTI-E, ANTI-D, AND ANTI-JKA WAS IDENTIFIED). THERE WAS NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1