BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2201414 · Received August 11, 2011

    Report

    Report Number
    1056600-2011-00074
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CHECKED THE FLUIDICS, INCUBATOR, CENTRIFUGE, REAGENT SPINNERS, AND GEL CAMERA. ALL WERE WITHIN SPECS. THE LOG FILES WERE REVIEWED AND NO ERRORS WERE OBSERVED TO ANY OF THE SAMPLES IN QUESTION. THE CUSTOMER RAN AND PASSED QC. THE INSTRUMENT IS OPERATING AS EXPECTED. NO REPAIRS NEEDED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ORTHO PROVUE RESULTED A 1+ REACTION AS NEGATIVE IN THE ANTI-E. ERRONEOUS RESULTS WERE REPORTED. TESTING WAS REPEATED AND RESULTS CORRECTED. CORRECTED REPORTS HAVE BEEN ISSUED FOR THE AFFECTED SAMPLES. 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 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1