BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISCREEN

    MDR report key: 2111655 · Received June 2, 2011

    Report

    Report Number
    2250051-2011-00125
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 14, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY WITH 3SS373 AND A PATIENT SAMPLE WITH A HISTORY OF ANTI-D. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS 3SS373

    Patients

    Seq Age Sex Outcome Treatment
    1