BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN FOR GEL

    MDR report key: 3090634 · Received May 2, 2013

    Report

    Report Number
    2250051-2013-00118
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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. SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CONTACTED CTS TO REPORT FALSE NEGATIVE REACTIONS IN THE MTS GEL SYSTEM WITH A PATIENT SAMPLE CONFIRMED TO HAVE ANTI-E, ANTI-C, AND ANTI-KELL DETECTED IN THE SOLID PHASE METHODOLOGY ON THE ECHO INSTRUMENT. CUSTOMER REPORTED THAT THE PATIENT WAS INITIALLY TESTED ON THE IMMUCOR ECHO AND YIELDED A POSITIVE REACTION. CUSTOMER STATED THAT IT IS THEIR PROTOCOL TO REPEAT ANY POSITIVE ANTIBODY SCREEN BY THE ECHO IN THE MANUAL GEL METHOD. PATIENT SAMPLE WAS THEN TESTED BY THE MANUAL GEL METHOD WITH A 15MIN INCUBATION AND NEGATIVE RESULTS WERE OBSERVED. CTS CONFIRMED ACCEPTABLE QC TO THE 0.8% SURIGSCREEN AND THE ANTI-IGG GEL CARDS. ALL LISTED OCD PRODUCTS HAVE BEEN CONFIRMED TO HAVE NORMAL APPEARANCE AND STORED ACCORDING TO THE RESPECTED IFU. CTS SUGGESTED ANTIGEN TYPING OF THE 0.8% DONORS THAT WERE EXPECTED TO BE POSITIVE FOR THE RESPECTIVE ANTIBODY. CUSTOMER IS UNWILLING TO PERFORM THE SUGGESTED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191880 0.8% SURGISCREEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS536

    Patients

    Seq Age Sex Outcome Treatment
    1