BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID-MTS A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 775949 · Received August 24, 2006

    Report

    Report Number
    1056600-2006-00117
    Event Type
    Malfunction
    Date Received
    August 24, 2006
    Date of Event
    July 24, 2006
    Report Date
    August 14, 2006
    Manufacturer
    MICRO TYPING SYSTEMS
    Product Code
    KSZ
    PMA / PMN Number
    stn103756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SUBMITTED FOR INVESTIGATION. CUSTOMER COMPLAINT WAS NOT VERIFIED AT MTS. SAMPLE IS A WEAK D 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, IMPROPER STORAGE AND HANDLING OF REAGENTS, LABORATORY 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+ 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 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 REPORTS THAT A PATIENT SAMPLE TESTED WITH MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 022806037-05 (EXP 20 JAN 07) 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 * 022806037-05

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other