BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISCREEN

    MDR report key: 1509350 · Received October 5, 2009

    Report

    Report Number
    2250051-2009-00287
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 5, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CLINICAL DIAGNOSTICS (OCD) PERFORMED RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY WITH 3SS111 AND A PT SAMPLE WITH ANTI-KELL. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS 3SS111

    Patients

    Seq Age Sex Outcome Treatment
    1