BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8 PERCENT SELECTOGEN

    MDR report key: 1482750 · Received July 17, 2009

    Report

    Report Number
    2250051-2009-00276
    Event Type
    Injury
    Date Received
    July 17, 2009
    Date of Event
    August 12, 2009
    Report Date
    September 17, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW WAS PERFORMED AND ALL IN-PROCESS AND QA RELEASE TESTING WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT VS288 DID NOT DETECT AN ANTIBODY IN A PT WHO WAS LATER CONFIRMED TO HAVE ANTI-C PRESENT IN THE PLASMA. CUSTOMER CLAIMED THEY SAW A FEW "FUZZY AGGLUNTINATES" WITH CELL II. CUSTOMER PERFORMED AN IMMEDIATE SPIN CROSS MATCH (TUBE METHOD). TWO UNITS WERE TRANSFUSED WITHOUT INCIDENT. IN 2009, A NEW SAMPLE WAS OBTAINED FROM PT AND NOW THE ANTIBODY SCREEN WAS POSITIVE (3+) WITH CELL II. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8 PERCENT SELECTOGEN REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS VS288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other