BEUDAMED
    FDA Adverse Event Death Summary report: N

    MTS ANTI-IGG CARD

    MDR report key: 811552 · Received February 1, 2007

    Report

    Report Number
    1056600-2007-00026
    Event Type
    Death
    Date Received
    February 1, 2007
    Date of Event
    January 10, 2007
    Report Date
    January 30, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO PROVIDED BY THE CUSTOMER AND THE RESULTS OF THE INVESTIGATION, THE GEL CARD REACTED AS EXPECTED BY CORRECTLY DETECTING THE PRESENCE OF ANTIBODIES DURING CROSSMATCH TESTING (INCOMPATIBLE). GEL CARD MALFUNCTION COULD NOT BE IDENTIFIED. THE CUSTOMER DID NOT PROVIDE INFO AS TO WHAT INFLUENCED THEIR DECISION TO TRANSFUSE THE PT WITH INCOMPATIBLE BLOOD. THIS COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE ADVERSE EVENT. THE CAUSE OF DEATH IS UNK BY MTS (THIS INFO WAS NOT PROVIDED BY THE CUSTOMER). IF A PT IS TRANSFUSED WITH ANTIGEN-POSITIVE BLOOD, THEY MAY SUFFER HEMOLYTIC TRANSFUSION REACTION. THE LIKELIHOOD OF A SERIOUS INJURY, WHILE NOT FREQUENT, IS NOT REMOTE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE CALL CENTER TO INQUIRE ABOUT THE KIND OF REACTIONS OBSERVED WITH ANTI-SDA AND ANTI-HENSHAW. BECAME AWARE OF THIS EVENT THROUGH CONVERSATION WITH THE CUSTOMER. A SAMPLE FROM A PT WITH MULTIPLE ANTIBODIES (ANTI-SDA, ANTI-HENSHAW) REACTED AS MIXED-FIELD DURING COMPATIBILITY/CROSSMATCH TESTING WITH 37 UNITS OF BLOOD. THE UNITS WERE TESTED USING 2 DIFFERENT LOTS OF MTS ANTI-IGG CARDS (LOT #080706001-33 AND 080706001-10). ONE OF THE INCOMPATIBLE UNITS WAS TRANSFUSED AND AFTER RECEIVING APPROX 50CC OF BLOOD THE PT HAD ELEVATED BLOOD PRESSURE AND EXPIRED. THE CUSTOMER DID NOT PROVIDE ANY OTHER INFO REGARDING THE INCIDENT. THIS MDR IS BEING FILED TO REPORT THE ADVERSE EVENT REPORTED BY THE CUSTOMER. THERE WAS NO MALFUNCTION OR PRODUCT PROBLEM WITH THE GEL CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-IGG CARD ANTIBODY SCREENING REAGENT KSZ MICRO TYPING SYSTEMS, INC. NA 080706001-33

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death