BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLVE PANEL A

    MDR report key: 2122333 · Received June 13, 2011

    Report

    Report Number
    2250051-2011-00140
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED AN INVESTIGATION. BATCH REVIEW WAS SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE CONTAINING ANTI-FYB DID NOT REACT WITH RA787 CELL 10. TESTING WAS PERFORMED IN TUBE. BASED UPON THIS LACK OF REACTIVITY, CUSTOMER WAS UNABLE TO IDENTIFY THE PATIENT'S ANTIBODY WITH THIS LOT. CUSTOMER WAS ABLE TO IDENTIFY THE ANTIBODY USING A COMPETITOR'S PRODUCT. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS RA787

    Patients

    Seq Age Sex Outcome Treatment
    1