BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1735888 · Received June 24, 2010

    Report

    Report Number
    2954323-2010-00856
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 13, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: ACCORDING TO THE HEALTH CARE PROVIDER, THE REPORTED READINGS WERE OBTAINED WITHIN TEN MINUTES. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED IN A PATIENT FOR APPROXIMATELY 3 MONTHS. ACCORDING TO THE COMPLAINANT, WHEN THE STENT WAS ATTEMPTED TO BE REMOVED, THE STENT BROKE. IT WAS REPORTED THAT RESISTANCE WAS MET, HOWEVER, WEAK FORCE WAS APPLIED BY THE PHYSICIAN. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT USING FORCEPS. THE STENT WAS FOUND TO BE STRETCHED. THE PATIENT WAS REPORTED TO BE IN "GOOD" CONDITION AT THE COMPLETION OF THE PROCEDURE.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER REPORTED CUSTOMER RECEIVED ERRATIC READINGS OF 460 MG/DL, 247 MG/DL, 400 MG/DL, 467 MG/DL AND 323 MG/DL FROM THEIR FREESTYLE FREEDOM LITE METER AT THE HEALTH CARE PROVIDER'S OFFICE. THE HEALTH CARE PROVIDER ALSO REPORTED PROVIDING CUSTOMER AN UNKNOWN TREATMENT WHICH CAUSED CUSTOMER TO EXPERIENCE SYMPTOMS OF SEIZURE. IT IS UNKNOWN IF THERE WAS ANY TREATMENT GIVEN TO THE CUSTOMER TO COUNTERACT HIS SYMPTOMS. THE HEALTH CARE PROVIDER REFUSED TO COMPLETE THE MEDICAL SURVEY. ADC CUSTOMER SERVICES ATTEMPTED TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION BUT WITHOUT ANY SUCCESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1003429

    Patients

    Seq Age Sex Outcome Treatment
    1 Other