BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 3101710 · Received May 9, 2013

    Report

    Report Number
    2250051-2013-00127
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING, BATCH RECORD REVIEW, AND COMPLAINT BY LOT REVIEW. ALL RESULTS WERE SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE, LATER IDENTIFIED TO HAVE AN ANTI-KELL, DID NOT REACT WITH VS623. THE PATIENT'S ANTIBODY WAS IDENTIFIED AT ANOTHER SITE. THE CUSTOMER REPEATED THE ANTIBODY SCREEN, NO REACTIVITY WAS OBSERVED. CUSTOMER REPORTS THAT OTHER PATIENTS WITH ANTI-KELL HAVE REACTED WITH THIS LOT OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202561 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS623

    Patients

    Seq Age Sex Outcome Treatment
    1