BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 2222128 · Received August 24, 2011

    Report

    Report Number
    2250051-2011-00220
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    October 14, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE LATER CONFIRMED TO HAVE AN ANTI-E DID NOT REACT WITH VS467. ACCORDING TO CUSTOMER, PATIENT SAMPLE WAS FIRST TESTED ON (B)(6) 2011 USING 0.8% SELECTOGEN LOT # VS467 WITH A NEGATIVE RESULT. THE PATIENT WAS NOT TRANSFUSED. ON (B)(6) 2011 ANOTHER SAMPLE WAS DRAWN FROM THE PATIENT. AN ANTIBODY SCREEN WAS PERFORMED AND CELL II WAS WEAKLY POSITIVE. CUSTOMER THEN PERFORMED ADDITIONAL TESTING AND ANTI-E WAS IDENTIFIED.

    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 VS467

    Patients

    Seq Age Sex Outcome Treatment
    1