BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1897102 · Received November 11, 2010

    Report

    Report Number
    2954323-2010-01546
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 25, 2010
    Report Date
    January 4, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 26 MG/DL AND 110 MG/DL 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 LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WHILE CREATING THE GASTRIC JEJUNOSTOMY ON THE SEVENTH OR EIGHTH FIRING THE RESIDENT CLOSED THE DEVICE. ON THE THIRD FIRING STROKE THE RESIDENT NOTICED EXTREME RESISTANCE AND COULD NOT FINISH THE FIRING. AT THAT TIME THE RESIDENT ASKED THE ANESTHESIOLOGIST TO PULL BACK ON THE GASTRIC TUBE AND HE MET RESISTANCE. THEY COULD NOT PULL BACK ON THE TUBING BECAUSE THE TUBING WAS IN TIP OF THE DEVICE. WHEN THE RESIDENT CLOSED THE DEVICE HE DID NOT FEEL ANY RESISTANCE. THE RESIDENT TRIED TO OPEN THE DEVICE AND HE COULD NOT GET THE DEVICE TO OPEN. THEY HAD TO CONVERT TO OPEN. THE DEVICE WAS ENTANGLED IN TISSUE AND THE TUBE. THEY HAD TO CUT THE DEVICE OFF THE GASTRIC TUBE AND TISSUE. NO EXTREME BLEEDING OCCURRED. THE SURGEON HAND SUTURED THE ANASTOMOSIS. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE ACCOUNT DOES NOT RELEASE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0919129

    Patients

    Seq Age Sex Outcome Treatment
    1