BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DISPENSE 1.0ML

    MDR report key: 789115 · Received November 17, 2006

    Report

    Report Number
    1056600-2006-00260
    Event Type
    Malfunction
    Date Received
    November 17, 2006
    Date of Event
    October 19, 2006
    Report Date
    November 17, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE MTS DISPENSER WAS LEAKING AND NOT DISPENSING PROPERLY. IT IS UNKNOWN IF THE ISSUE WAS OBSERVED DURING TESTING. CUSTOMER LABELING INSTRUCTS CUSTOMER TO PERFORM QC PRIOR TO ALL TESTING INVOLVING MTS GEL CARDS. VARIATIONS IN RED BLOOD CELL CONCENTRATION CAN MARKEDLY AFFECT THE SENSITIVITY OF TEST RESULTS. IF RED BLOOD CELL SUSPENSIONS ARE TOO CONCENTRATED, THEY CAN GIVE WEAKER RESULTS DUE TO THE INCREASE IN THE ANTIGEN/ANTIBODY RATIO. IN ADDITION, RED BLOOD CELLS MAY FAIL TO COMPLETELY MIGRATE TO THE BOTTOM OF THE MICROTUBE AND COULD CAUSE A FALSE POSITIVE INTERPRETATION. WHEN RED BLOOD CELLS ARE TOO LOW IN CONCENTRATION, THEY BECOME DIFFICULT TO VISUALIZE, AND IN EXTREME CASES, A WEAK POSITIVE CAN FAIL TO BE DETECTED. ERRONEOUS RESULTS WERE NOT REPORTED AS A RESULT OF THIS INCIDENT. THE CUSTOMER ISSUE WAS RESOLVED VIA REPLACEMENT OF PRODUCT. ALTHOUGH THESE MITIGATIONS EXIST IF THE INCIDENT WERE TO RECUR UNDETECTED A POSSIBLE ERRONEOUS RESULT MAY OCCUR. THE ISSUE WAS NOT IDENTIFIED DURING A CALIBRATION OF QC. THEREFORE, INCIDENT IS REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 1.0 ML MTS DISPENSER WAS LEAKING AND NOT DISPENSING THE CORRECT AMOUNT OF VOLUME. IT IS UNKNOWN IF THE INSTRUMENT WAS BEING USED FOR PATIENT TESTING AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS DISPENSE 1.0ML MTS DISPENSER 1.0ML GJG MICRO TYPING SYSTEMS, INC. MTS9612 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *