BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID-MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD

    MDR report key: 791016 · Received November 27, 2006

    Report

    Report Number
    1056600-2006-00346
    Event Type
    Malfunction
    Date Received
    November 27, 2006
    Date of Event
    October 31, 2006
    Report Date
    November 25, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS SUBMITTED FOR INVESTIGATION. CUSTOMER COMPLAINT WAS NOT VERIFIED AT MTS. SAMPLE IS A WEAK D EXAMPLE REACTING CONSISTENTLY IN ANTI-D GEL AND POSITIVE IN TUBE AT AHG PHASE ONLY AT MTS. MTS IS UNABLE TO EXPLAIN FALSE NEGTIVE REACTIONS OBSERVED BY THE CUSTOMER IN THE ANTI-D MICROTUBE. ALTHOUGH INCIDENT APPEARS TO BE SAMPLE RELATED, MTS IS UNABLE TO RULE OUT GEL CARD MALFUNCTION AND/OR USER ERROR 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 POSTIVE 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 NEG. ALTHOUGH SERIOUS TRANSFUSION REACTIONS DUE TO ANTI-D ARE NOT USUAL, THEY ARE PROBABLY NOT REMOTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT'S SAMPLE TESTED WITH MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT# 022806037-32 FAILED TO REACT IN THE ANTI-D MICROTUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ID-MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD A/B/D MONOCLONAL & REVERSE GROUPING CARD KSZ MICRO TYPING SYSTEMS, INC. * 022806037-32

    Patients

    Seq Age Sex Outcome Treatment
    1 *