BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTS ANTI-IGG CARD

    MDR report key: 1915162 · Received December 6, 2010

    Report

    Report Number
    1056600-2010-00137
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT DATA BASE INDICATES THAT THEREA RE NO SIMILAR COMPLAINTS AGAINST THIS LOT.OCD MEDICAL HAS ASSESSED THIS AS A SERIOUS INJURY.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN INCOMPATIBLE CROSSMATCH IN GEL. THE PATIENT HAD SEVERAL NEGATIVE ANTIBODY SCREENS AND HAD RECEIVED SEVERAL UNITS OF BLOOD. ABOUT ELEVEN DAYS AFTER THE LAST TRANSFUSION, THE ANTIBODY SCREEN WAS NOTED TO BE POSITIVE, AUTOCONTROL WAS NEGATIVE AND AN ANTI-E WAS IDENTIFIED. TWO DAYS LATER, THE AUTOCONTROL WAS POSITIVE (1+) AND THE IGG DAT IN GEL WAS 1+. AN ANTI-E WAS IDENTIFIED FROM THE ELUATE. OF THE 5 UNITS THAT THE PATIENT RECEIVED, ONE UNIT WAS POSITIVE FOR THE E ANTIGEN; THE REST OF THE UNITS WERE E NEGATIVE. ON CROSSMATCH ALL 5 UNITS WERE COMPATIBLE INCLUDING THE ONE E POSITIVE UNIT. THIS UNIT WAS COMPATIBLE IN GEL AND INCOMPATIBLE IN TUBE USING PEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-IGG CARD ANTIBODY SCREENING REAGENT KSZ MICROTYPING SYSTEMS 082610001-21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other