BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1880710 · Received October 25, 2010

    Report

    Report Number
    2954323-2010-01472
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 6, 2010
    Report Date
    December 16, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS WERE RETURNED AND INVESTIGATED. THE COMPLAINT IS NOT CONFIRMED. 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 READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. 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 SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 20 MMOL/L, 3.4 MMOL/L AMD 9.2 MMOL/L 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

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 31 MONTHS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. THE INFRARENAL AORTIC NECK WAS SHORT AND MEASURED 35 MM IN DIAMETER AND THEN PINCHED DOWN TO LESS THAN 26 MM IN DIAMETER. THE PT WAS NOT A SURGICAL CANDIDATE. IT WAS REPORTED THAT DUE TO THE DIFFICULT NECK ANATOMY, AN ANEURX CUFF WAS ALSO IMPLANTED PROXIMALLY IN A PLANNED PLACEMENT; HOWEVER, THE ORIGINAL PLACEMENT POSITION OF THE CUFF IS UNK. THE PT WAS LOST TO F/U AND PRESENTED EMERGENTLY ON (B)(4) 2010, WITH PROXIMAL TYPE 1 ENDOLEAK AND A RUPTURED ANEURYSM. THE CUFF WAS LOCATED 15 MM BELOW THE RENAL ARTERIES, BUT STENT GRAFT MIGRATION CANNOT BE CONFIRMED. THE PHYSICIAN CONVERTED THE PT TO AN OPEN REPAIR AND EXPLANTED THE STENT GRAFTS (SEE MFR # 2953200-2010-02530). THE EXPLANTED STENT GRAFTS WERE DISCARDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1017914

    Patients

    Seq Age Sex Outcome Treatment
    1