BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID-MTS A/B/D MONOCLONAL & REVERSE GOUPING CARD

    MDR report key: 842980 · Received October 20, 2006

    Report

    Report Number
    1056600-2006-00304
    Event Type
    Malfunction
    Date Received
    October 20, 2006
    Date of Event
    September 22, 2006
    Report Date
    October 20, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    MTS RECEIVED A SAMPLE FOR INVESTIGATION. CUSTOMER COMPLAINT WAS NOT VERIFIED AT MTS. PT IS MOST LIKELY A PARTIAL D EXAMPLE ( WEAK D) WITH ANTI-D, REACTING CONSISTENTLY IN ANTI-D GEL AT MTS. THIS MAY EXPLAIN THE POS DAT AND AUTO CONTROL OBTAINED BY THE CUSTOMER AND ALSO AT MTS IN TUBE. ALTHOUGH INCIDENT IS MOST LIKELY SAMPLE RELATED, GEL CARD MALFUNCTION CANNOT BE RULED OUT. LABELING CAUTIONS THE USER AS FOLLOWS: VERY WEAK EXPRESSIONS OF THE D ANTIGEN MAY NOT BE DETECTED BY THE MTS MONOCLONAL ANTI-D GEL CARD. IN INSTANCES WHERE CONFIRMATION OF D NEGATIVE ANTIGEN STATUS IS REQUIRED, NEGATIVE D REACTIONS OBTAINED WITH THE MTS MONOCLONAL ANTI-D SHOULD BE RETESTED WITH AN ANTI-D REAGENT LICENSED FOR ANTIGLOBULIN PHASE TESTING. LESS THAN OPTIMAL TEST CELL CONCENTRATIONS MAY RESULT IN TEST REACTIONS, WHICH CANNOT BE FULLY OBSERVED. A D+ PT ERRONEOUSLY TYPED AS D NEGATIVE: (1) WOULD RECEIVE D NEGATIVE BLOOD AND (2) MIGHT RECEIVE ANTI-D IMMUNOGLOBULIN DURING OR AFTER PREGNANCY OR AFTER TRANSFUSION OF D POSITIVE BLOOD TRANSFUSION OF D NEGATIVE BLOOD PRODUCTS TO A D POSITIVE PT IS OF NO CLINICAL SIGNIFICANCE. THE UNNECESSARY RECEIPT OF ANTI-D IMMUNOGLOBULIN CARRIES A RISK OF ADVERSE REACTIONS. THE LIKELIHOOD OF A SERIOUS INJURY IS REMOTE IN THIS SITUATION. A FALSE NEGATIVE RESULT WOULD LEAD TO WITHHOLDING OF ANTI-D IMMUNOGLOBULIN IN A NON-RHD IMMUNIZED MOTHER AND SUBSEQUENT RISK (1-10%) OF D IMMUNIZATION. THE SEVERITY LEVEL IS SEVERE/LIFE THREATENING DUE TO THE CUMULATIVE POTENTIAL RISKS OF A FALSE NEGATIVE. ALTHOUGH SERIOUS TRANSFUSION REACTIONS DUE TO ANTI-D ARE NOT USUAL, THEY ARE NOT REMOTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT'S SAMPLE TESTED WITH MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT # 042806037-13 FAILED TO REACT IN THE ANTI-D MICROTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ID-MTS A/B/D MONOCLONAL & REVERSE GOUPING CARD A/B/D MONOCLONAL $ REVERSE GROUPING CARD KSZ MICRO TYPING SYSTEMS, INC. * 042806037-13

    Patients

    Seq Age Sex Outcome Treatment
    1 *