BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-IGG, -C3D CARD

    MDR report key: 1458586 · Received May 8, 2009

    Report

    Report Number
    1056600-2009-00097
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Date of Event
    April 14, 2009
    Report Date
    May 7, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC,
    Product Code
    CFQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SATISFACTORY RESULTS WERE OBTAINED AT OCD USING RETAINED CARDS FROM MTS ANTI-IGG - C3D CARD LOT # 071608005-04 AND MTS ANTI-IGG CARD LOT # 112408001-30 USING KNOWN DAT POSITIVE AND NEGATIVE SAMPLES. THE GEL CARDS PERFORMED AS EXPECTED AT OCD. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE SAMPLE IN QUESTION WAS SUBMITTED TO OCD FOR ADD'L TESTING. A DEFINITE ROOT CAUSE WAS NOT DETERMINED REGARDING THE NEGATIVE RESULTS OBTAINED AT THE CUSTOMER SITE. A COMPLAINT REVIEW INDICATED NO OTHER COMPLAINTS HAVE BEEN LOGGED AGAINST LOT# 071608005-04. BATCH RECORD REVIEW WAS WITHIN RELEASE SPECIFICATIONS. INCIDENT IS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DAT POSITIVE SAMPLE FAILED TO REACT IN THE MTS ANTI-IGG, -C3D CARD LOT# 071608005-04. THE SAMPLE REACTED POSITIVE (1+) USING THE MTS ANTI-IGG CARD. A FALSE NEGATIVE DAT MAY LEAD TO CONFUSION IN THE DIAGNOSIS OF ANEMIA OR MISDIAGNOSIS OF A HEMOLYTIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-IGG, -C3D CARD ANTI-HUMAN GLOBULIN REAGENT CFQ MICRO TYPING SYSTEMS, INC, NA 071608005-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other