BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1586354 · Received January 11, 2010

    Report

    Report Number
    2250051-2010-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 12, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 VRA136 AND TWO PT SAMPLES WITH ANTI-E WITH A 15 MINUTE INCUBATION. WEAK REACTIVITY WAS OBSERVED AT 30 MINUTES. 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, INC. VRA136

    Patients

    Seq Age Sex Outcome Treatment
    1