BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1834065 · Received September 14, 2010

    Report

    Report Number
    2250051-2010-00210
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 29, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING AND BATCH RECORD REVIEW WERE PERFORMED. SATISFACTORY RESULTS WERE OBSERVED.(B)(4)

    Description of Event or Problem · 1

    PATIENT WITH NO PREVIOUS ANTIBODY HISTORY AND A POSITIVE ANTIBODY SCREEN DID NOT REACT WITH VRA146. COMPATIBILITY TESTING WAS PERFORMED AND 3 UNITS OF COMPATIBLE BLOOD WERE TRANSFUSED. PATIENT SHOWED NO SIGNS/SYMPTOMS OF A TRANSFUSION REACTION DURING THE TRANSFUSION. PATIENT WAS LATER IDENTIFIED AS HAVING AN ANTI-E WHEN TESTING WAS PERFORMED WITH FICIN TREATED CELLS. TWO OF THE UNITS OF PACKED CELLS THAT HAD BEEN TRANSFUSED WERE E+. THE FOLLOWING DAY THE PATIENT HAD A POSITIVE DAT AND ANTI-E WAS IDENTIFIED IN THE ELUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other