BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1509351 · Received October 5, 2009

    Report

    Report Number
    2250051-2009-00286
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    September 15, 2009
    Report Date
    October 5, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 VRA132 AND A PT WITH A HISTORY OF ANTI-FYA WHEN TESTING WAS PERFORMED AT A 15 MINUTE INCUBATION. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS VRA132

    Patients

    Seq Age Sex Outcome Treatment
    1