BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD

    MDR report key: 789752 · Received November 21, 2006

    Report

    Report Number
    1056600-2006-00270
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Date of Event
    October 31, 2006
    Report Date
    November 21, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    MTS RECEIVED A SAMPLE FOR INVESTIGATION. CUSTOMER COMPLAINT WAS VERIFIED AT MTS. SAMPLE IS A WEAK D EXAMPLE, REACTING NEGATIVE IN ANTI-D GEL AND POSITIVE IN TUBE AT AHG PHASE ONLY. ALTHOUGH INCIDENT IS MOST LIKELY SAMPLE RELATED, GEL CARD MALFUNCTION COULD NOT 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+ PATIENT 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 PATIENT IS OF NON 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 NEG. ALTHOUGH SERIOUS TRANSFUSION REACTIONS DUE TO ANTI-D ARE NOT USUAL, THEY ARE PROBABLY NOT REMOTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT, A PATIENT'S SAMPLE TESTED WITH MTS A/B/D MONOCLONAL GROUPING CARD LOT 062706037-03 GAVE NEGATIVE REACTIONS IN THE ANTI-D MICROTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD MTS A/B/D MONOCLONAL & REVERSE GROUPING KSZ MICRO TYPING SYSTEMS, INC. * 062706037-03

    Patients

    Seq Age Sex Outcome Treatment
    1 *