BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3841243 · Received May 30, 2014

    Report

    Report Number
    1056600-2014-00029
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON 5-22-2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CLEANED THE SAMPLE CAMERA LENS. FE DID A SAMPLE CAMERA ALIGNMENT AND OPTICS ADJUSTMENT. FE READ SAMPLE BARCODE LABELS MULTIPLE TIMES AND THEY READ CORRECTLY. CUSTOMER LOADED SAMPLES AND THEY WERE READ CORRECTLY. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS TWO INCIDENTS OF THE ORTHO PROVUE SAMPLE CAMERA MISREADING SAMPLE BARCODE LABELS. NO ERRONEOUS RESULTS WERE REPORTED. THIS IS INCIDENT 1 OF 2. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319149 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1