BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-IGG CARD

    MDR report key: 1352498 · Received February 10, 2009

    Report

    Report Number
    1056600-2009-00023
    Event Type
    Malfunction
    Date Received
    February 10, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 11, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED AND RETURNED TESTING PERFORMED AT OCD USING RETURNED SAMPLE WAS SATISFACTORY. THE CUSTOMER INDICATED THAT THE SAMPLE CONTAINED ANTI-K AND ANTI-JKA. HOWEVER, TESTING AT OCD IDENTIFIED ANTI-K AND ANOTHER UNIDENTIFIED ANTIBODY. THE SAMPLE WAS NOT SUFFICIENT TO PERFORM FURTHER TESTING. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. GEL CARDS PERFORMED AS EXPECTED AT THE OCD SITE AND NO FALSE NEGATIVE REACTIVITY WERE OBSERVED IN ANY OF THE GEL CARDS. BATCH RECORD REVIEW WAS WITHIN RELEASE SPECIFICATIONS. INCIDENT IS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT'S SAMPLE CONTAINING ANTI-K AND ANTI-JKA FAILED TO REACT IN THE MTS ANTI-IGG CARD LOT # 082908001-12. NO ERRONEOUS RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    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 082908001-12

    Patients

    Seq Age Sex Outcome Treatment
    1