BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1832086 · Received September 13, 2010

    Report

    Report Number
    2954323-2010-01259
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 18, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMERS PRODUCTS WERE 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 WERE FOUND IN METER MEMORY HOWEVER, WERE LOCATED OUTSIDE THE TEN MINUTE TIMEFRAME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 30 CAROTID STENT IMPLANTED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (RICA) TARGET LESION. THE REPORT STATED THAT THE PHYSICIAN HAD DIFFICULTY CLOSING/CAPTURING THE 6 MM ANGIOGUARD EMBOLIC FILTER BASKET. THE PHYSICIAN'S NOTES STATED THAT WHILE ATTEMPTING TO REMOVE THE BASKET IT BECAME STUCK AND RE-DEPLOYED IN THE CATHETER. THE PHYSICIAN THEN RE-FLUSHED THE SYSTEM AND WAS ABLE TO SUCCESSFULLY CAPTURE AND REMOVE THE ANGIOGUARD DEVICE. THERE WAS NO DEBRIS NOTED IN THE FILTER BASKET. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT WAS SYMPTOMATIC FOR THE INDEX PROCEDURE. THE RICA TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, 10 MM LENGTH, 6.0 MM REFERENCE DIAMETER, SEVERELY TORTUOUS, MODERATELY CALCIFIED, AND ECCENTRIC. THE LESION WAS PRE-DILATED. A PRECISE 8 X 30 STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 98 MG/DL, 77 MG/DL, 97 MG/DL, 200 MG/DL, 71 MG/DL, 31 MG/DL, AND 40 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 1011144

    Patients

    Seq Age Sex Outcome Treatment
    1