BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID-MTS A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 874142 · Received September 12, 2006

    Report

    Report Number
    1056600-2006-00144
    Event Type
    Malfunction
    Date Received
    September 12, 2006
    Date of Event
    January 7, 2005
    Report Date
    September 11, 2006
    Manufacturer
    MICRO TYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MTS RECEIVED A SAMPLE FOR INVESTIGATION. CUSTOMER COMPLAINT WAS NOT VERIFIED AT MTS. SAMPLE IS A D ANTIGEN REACTING CONSISTENTLY IN GEL. MTS IS UNABLE TO EXPLAIN FALSE NEGATIVE REACTIONS OBSERVED BY THE CUSTOMER IN THE ANTI-D MICROTUBE. MTS CQ CANNOT RULE OUT CUSTOMER ERROR, LAB TECHNIQUE AND TEST PREPARATION AS CONTRIBUTING FACTORS. 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. STN103756.

    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 # 063004037-30 (EXP 12 JUL 05) GAVE NEGATIVE REACTIONS IN THE ANTI-D MICROTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ID-MTS A/B/D MONOCLONAL GROUPING CARD BLOOD GROUPING REAGENT KSZ MICRO TYPING SYSTEMS * 063004037-30

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other