BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN

    MDR report key: 1586308 · Received January 7, 2010

    Report

    Report Number
    2250051-2009-00358
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    December 4, 2009
    Report Date
    January 7, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 VS315 AND A PT WITH ANTI-M. REACTIVITY WAS OBSERVED WITH 0.8% RESOLVE PANEL A, VRA135. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS VS315

    Patients

    Seq Age Sex Outcome Treatment
    1