BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% SELECTOGEN

    MDR report key: 1740348 · Received June 29, 2010

    Report

    Report Number
    2250051-2010-00161
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO-CLINICAL DIAGNOSTICS PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED.(B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A WEAK (B)(4) WAS NOT DETECTED DURING THE ANTIBODY SCREEN IN MANUAL GEL. AN IMMEDIATE SPIN CROSSMATCH WAS PERFORMED AND ONE UNIT OF PACKED RED CELLS WAS TRANSFUSED TO THE PATIENT. THE PATIENT SUFFERED A TRANSFUSION REACTION, WITH FEVER AND CHILLS. THE TRANSFUSION WAS STOPPED AND A WORK-UP INITIATED. CUSTOMER WAS ABLE TO IDENTIFY (B)(4) USING (B)(4). CUSTOMER INDICATED THAT THE UNIT OF PACKED CELLS TRANSFUSED TO PATIENT WAS C +. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS EVENT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS362

    Patients

    Seq Age Sex Outcome Treatment
    1 Other