BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1843110 · Received September 23, 2010

    Report

    Report Number
    2954323-2010-01326
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 7, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE BLOOD GLUCOSE TESTS ON THEIR FREESTYLE LITE METER. THE CUSTOMER REPORTED COMPARING A READING OF 399 MG/DL TO A LAB RESULT OF 170 MG/DL. THE BLOOD TESTS WERE REPORTEDLY COMPLETED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOSCOPIC LEFT LOWER LOBECTOMY PROCEDURE, ALTHOUGH ALL THE STAPLES WERE DEPLOYED, THE STAPLES WERE MALFORMED. THE KNIFE MOVED FORWARD PROPERLY. THE EVENT OCCURRED WHEN THE DEVICE WAS FIRED ON THE BRONCHIAL TUBES BETWEEN THE LUNG BASE AND B6. THE TISSUE WAS NOT CALCIFIED, BUT THICK AND HARD. ALTHOUGH THE ARTICULATION LEVER WAS USED, IT WAS NOT FULLY BENT. IT WAS A LITTLE HARD TO GRASP THE CLOSING LEVER, BUT IT COULD BE GRASPED. ALSO, THE FIRING WAS A LITTLE HARD, BUT THE FIRING TRIGGER COULD BE GRASPED. THE EDGE OF THE BRONCHIAL TUBES WAS NOT OPENED JUST AFTER THE FIRING BECAUSE OF PRESSURE BONDING. AFTER THE RESECTED LUNG WAS REMOVED, IT WAS FOUND THAT THE STAPLE LINE HAD OPENED. ALSO, THERE WERE SOME UNFORMED STAPLES INSIDE THE THORACIC CAVITY. THE SMALL INCISION WAS BROADENED OUT A LITTLE AND ADDITIONAL SUTURE WAS PERFORMED WITH A NEEDLE-HOLDER. A NEEDLE COULD BE PRICKED EASILY AT THE TARGET TISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0935633

    Patients

    Seq Age Sex Outcome Treatment
    1