BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 2901448 · Received January 8, 2013

    Report

    Report Number
    2250051-2013-00005
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    August 21, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED A BATCH RECORD REVIEW AND A COMPLAINT REVIEW FOR THIS LOT OF PRODUCT. SATISFACTORY RESULTS WERE OBSERVED. RETAINED TESTING WAS NOT PERFORMED DUE TO RECEIPT OF COMPLAINT BEYOND THE DATING OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT A PATIENT'S SAMPLE WAS TESTED USING VS567 ON (B)(6) 2012. THE ANTIBODY SCREEN WAS REPORTED AS NEGATIVE, SO THE FACILITY CROSSMATCHED TWO UNITS OF PACKED CELLS VIA IMMEDIATE SPIN. NO PROBLEMS REPORTED WITH TRANSFUSION. CUSTOMER CLAIMED ON (B)(6) 2012, A NEW SAMPLE WAS TESTED USING VS576 WITH POSITIVE REACTION NOTED (2+). DAT TEST WAS POSITIVE (2+) AND ELUATE WAS POSITIVE (2+). ANTI-E WAS IDENTIFIED. CUSTOMER STATED BECAUSE OF RECENT TRANSFUSION HISTORY, A "DELAYED TRANSFUSION WORK-UP WAS PERFORMED." CUSTOMER CLAIMED ANTI-E WAS IDENTIFIED. CUSTOMER FURTHER INDICATED THAT ALL DAILY QC TESTING WAS PERFORMED AND REACTIONS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8788 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS567

    Patients

    Seq Age Sex Outcome Treatment
    1