BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1912910 · Received December 2, 2010

    Report

    Report Number
    2954323-2010-01631
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 11, 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 NOT 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

    IT WAS REPORTED THAT WHILE PREPARING FOR A BILIARY DRAINAGE TREATMENT PROCEDURE, THE DEVICE WAS NOTED TO BE CRUSHED AND FOREIGN MATERIAL WAS FOUND ON THE DEVICE. A FLEXIMA BILIARY 8F 35CM WAS SELECTED. IT WAS CONFIRMED PRIOR TO OPENING THAT THE DEVICE APPEARED TO BE DAMAGED. ONCE OPENED, IT WAS FOUND THAT APPROXIMATELY 1/4 INCH SEGMENT OF THE LOOP END OF THE CATHETER WAS CRUSHED. FURTHERMORE, A VERY SMALL PIECE OF PAPER WAS STUCK TO THE CATHETER. IT WAS REPORTED THAT IT APPEARED TO BE REMNANTS OF ADHESIVE THAT HAD BEEN PULLED OFF WITH A SMALL SEGMENT REMAINING. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 455 MG/DL AND 126 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1010640

    Patients

    Seq Age Sex Outcome Treatment
    1