BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 2894958 · Received November 14, 2008

    Report

    Report Number
    2250051-2008-00495
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO-CLINICAL DIAGNOSTICS (OCD) PERFORMED A BATCH RECORD REVIEW TO ENSURE ALL SPECS WERE MET. REVIEW WAS SATISFACTORY. TESTING OF THE RETAINED PRODUCT WAS NOT ABLE TO BE PERFORMED DUE TO EXPIRATION OF PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO CLINICAL DIAGNOSTICS TO REPORT A FALSE NEGATIVE REACTION WITH A PT SAMPLE CONFIRMED TO HAVE AN ANTI-K. NO DISCREPANCIES WERE REPORTED WITH QC TESTING. NO DEATH OR SERIOUS INJURY HAS BEEN ASSOCIATED WITH THIS INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA VS210

    Patients

    Seq Age Sex Outcome Treatment
    1