BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD

    MDR report key: 789761 · Received November 21, 2006

    Report

    Report Number
    1056600-2006-00271
    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
    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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *