BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID-MTS A/B/D MONCLONAL GROUPING CARD

    MDR report key: 773821 · Received September 19, 2006

    Report

    Report Number
    1056600-2006-00116
    Event Type
    Malfunction
    Date Received
    September 19, 2006
    Date of Event
    July 19, 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. SAMPLE IS A WEAK D. FALSE NEGATIVE REACTIVITY WAS ONLY OBSERVED WITH THE RETURNED CARDS. SAMPLE REACTED AS EXPECTED WITH ALL RETAINS LOTS TESTED. MTS IS UNABLE TO EXPLAIN FALSE NEGATIVE REACTIONS OBSERVED BY THE CUSTOMER IN THE ANTI-D MICROTUBE. INCIDENT IS ISOLATED 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 WITHOLDING 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 SAMPLE TESTED WITH MTS A/B/D MONOCLONAL GROUPING CARE LOT 11105053-01 (EXP 11 AUG 2006) 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 MONCLONAL GROUPING CARD BLOOD GROUPING REAGENT KSZ MICRO TYPING SYSTEMS * 040606053-0

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other