BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 4048647 · Received August 29, 2014

    Report

    Report Number
    1056600-2014-00047
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT WAS INVESTIGATED. ON (B)(6) 2014, AN OCD FE (FIELD ENGINEER) VISITED THE SITE AND VERIFIED READER CAMERA OPTICS ADJUSTMENT. PERFORMED READER REFERENCE AND PROCESSED WADD DIAGNOSTIC TEST TO VERIFY ANALYZER. CUSTOMER PROCESSED QUALITY CONTROLS AND ACCEPTED RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTING FALSE NEGATIVE REACTION IN THE ANTI-D MICROWELL (RH). PATIENT WAS INITIALLY TESTED ON PROVUE ON (B)(6) 2014 AND WAS TYPED AS GROUP O, RH POS. PATIENT WAS TRANSFUSED TWO UNITS OF GROUP O, RH NEGATIVE PACKED RED CELLS ON (B)(6) 2014. NEW SAMPLE WAS TESTED ON (B)(6) 2014 ON PROVUE AND NOW THE ANTI- D MICROWELL (RH MICROWELL) SHOWED NO REACTION AND PROVUE GAVE A RESULT OF GROUP O, RH NEGATIVE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530553 ORTHO PROVUE AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1