BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN

    MDR report key: 1903393 · Received November 19, 2010

    Report

    Report Number
    2250051-2010-00244
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. RESULTS WERE SATISFACTORY. THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS LOT OF PRODUCT. (B)(4).

    Description of Event or Problem · 1

    ONE PATIENT WITH AN ANTI-LEA FAILED TO REACT WITH VS399 CELL I. PANEL (LOT NOT AVAILABLE) CLEARLY SHOWED ANTI-LEA. PEG SCREEN USING ANOTHER MANUFACTURER'S REAGENTS ALSO SHOWED ANTI-LEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS399

    Patients

    Seq Age Sex Outcome Treatment
    1