BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVE PANEL A FOR GEL

    MDR report key: 1415426 · Received July 2, 2009

    Report

    Report Number
    2250051-2009-00208
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    May 26, 2009
    Report Date
    July 2, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO UNITS TRANSFUSED IN 2009 WERE TYPED RETROSPECTIVELY; ONE UNIT WAS FOUND TO BE POSITIVE FOR E AND THE OTHER UNIT WAS POSITIVE FOR C. AS PER PT'S PHYSICIAN, PT IS NON SYMPTOMATIC AND IS STABLE. ORTHO-CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE HAD PREVIOUSLY PERFORMED A BATCH REVIEW AND RETAINED TESTING OF THE E ANTIGEN TO CONFIRM REACTIVITY. RESULTS WERE SATISFACTORY. TESTING OF THE C ANTIGEN WAS NOT POSSIBLE DUE TO RECEIPT OF COMPLAINT BEYOND EXPIRATION DATING.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS TO REPORT THAT A WEAK ANTI-E AND ANTI-C WERE MISSED PRETRANSFUSION BY THE 0.8% RESOLVE PANEL A, VRA 128, USING MANUAL GEL METHOD. AN ANTI-FYA WAS IDENTIFIED WITH VRA 128. 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. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS EVENT AS A SERIOUS INJURY DUE TO HEMOLYSIS OF TRANSFUSED CELLS WHICH RESULTED FROM A FALSE NEGATIVE ANTIBODY IDENTIFICATION. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A FOR GEL REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS NA VRA128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other