BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL C FOR GEL

    MDR report key: 1413713 · Received July 2, 2009

    Report

    Report Number
    2250051-2009-00209
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    May 26, 2009
    Report Date
    July 2, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE E AND C ANTIGENS WAS NOT POSSIBLE DUE TO RECEIPT OF COMPLAINT BEYOND EXPIRATION DATING. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED AGAINST THIS LOT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS TO REPORT THAT A WEAK ANTI-E & ANTI-C WERE NOT IDENTIFIED DURING A TRANSFUSION WORK-UP WITH THE UNTREATED 0.8% RESOLVE PANEL C, VRC 127. THE PT INITIALLY RECEIVED TWO UNITS OF CROSSMATCH-COMPATIBLE FYA NEGATIVE BLOOD IN 2009. CUSTOMER CONTINUED THE TRANSFUSION WORK-UP SINCE ONE OF THE SCREENING CELLS THAT WAS NEGATIVE FOR THE FYA ANTIGEN WAS POSITIVE. ANTI-E AND ANTI-C WERE LATER IDENTIFIED WITH FICIN TREATED CELLS OF VRC 127. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL C FOR GEL REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS NA VRC127

    Patients

    Seq Age Sex Outcome Treatment
    1