BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 5821020 · Received July 25, 2016

    Report

    Report Number
    1056600-2016-00048
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 16, 2016
    Report Date
    July 25, 2016
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTED DISCREPANCIES NOTED WITH QC. CUSTOMER REPORTS STORING ALL CARDS AND REAGENTS ACCORDING TO IFU. THE PATIENT RECEIVED 2 UNITS OF O NEGATIVE CELLS. PROVUE RESULTS ARE CONSISTENT WITH THE TRANSFUSED CELLS. CTS PROVIDED CUSTOMER WITH CUSTOMER LETTER (B)(4) WHICH EXPLAINS THE HOW THE PROVUE PROBE ASPIRATES FROM THE BOTTOM OF THE TUBE WHERE THE TRANSFUSED CELL ARE LIKELY TO BE. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS SAMPLE RELATED DUE TO THE TRANSFUSION. CUSTOMER IS SATISFIED WITH THE EXPLANATION, NO OTHER CONCERNS WITH THE INSTRUMENT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED CTS TO REPORT A FALSE NEGATIVE REACTION RESULT BY THE PROVUE IN THE FORWARD ANTI-D MICROWELL. THE SAMPLE WAS TESTED ON (B)(6) TYPING AS O NEGATIVE WHILE PATIENT HISTORY IS O POS. THE PATIENT WAS TESTED ON (B)(6) AS AN O POS AND WAS TRANSFUSED TWO RBC UNITS OF O NEGATIVE. NO REPORTS OF ANY INCORRECT OR ERRONEOUS RESULTS REPORTED AS A RESULT OF THIS REPORTED CONCERN. NO REPORTS OF ANY ADVERSE REACTIONS WITH THESE TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473982 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1