BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL Z

    MDR report key: 2666824 · Received August 28, 2008

    Report

    Report Number
    2250051-2008-00421
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS RARITAN
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THE TRANSFUSED UNIT WAS NOT TYPED RETROSPECTIVELY TO DETERMINE IF IT WAS POSITIVE FOR THE E ANTIGEN. ORTHO CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAIN TESTING OF VRA117 TO CONFIRM THE PRESENCE OF THE E ANTIGEN; SATISFACTORY RESULTS WERE OBSERVED. A POST TRANSFUSION SAMPLE WAS ALSO TESTED. TESTING WAS PERFORMED WITH VRA117 (EXPIRED); WEAK REACTIVITY WAS OBSERVED WITH 2 OF 10 E+ CELLS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS TO REPORT A FALSE NEGATIVE REACTION FOR ANTI-E WITH VRA117. ON (B)(6) 2008, A SPECIMEN WAS OBTAINED AND TESTED WITH VRA117. ANTI-C WAS IDENTIFIED, BUT ANTI-E WAS NOT REPORTED. ONE UNIT OF PACKED CELLS WAS TRANSFUSED TO THE METASTATIC MELANOMA PT ON (B)(6) 2008. ON (B)(6) 2008, A NEW SAMPLE WAS OBTAINED AND TESTED WITH VRA118. ANTI-C WAS IDENTIFIED, BUT ANTI-E WAS NOT REPORTED. A PEG/TUBE PANEL WAS ALSO PERFORMED. IN ADDITION TO THE ANTI-C, AN ANTI-E WAS ALSO IDENTIFIED. NO DISCREPANCIES WERE REPORTED WITH QC TESTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL Z REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS RARITAN VRA117

    Patients

    Seq Age Sex Outcome Treatment
    1