BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1911972 · Received December 1, 2010

    Report

    Report Number
    2954323-2010-01621
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 2, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. CUSTOMER'S METER (B)(4) WAS RETURNED AND TESTED WITH TEST STRIPS LOT # 1067323. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION. ADDITIONALLY, THE REPORTED READINGS WERE FOUND IN THE DEVICE'S INTERNAL MEMORY LOG WITHIN 10 MINUTES. NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 1.1 MMOL/L TO 27.8 MMOL/L. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 27.8 MMOL/L. A BLOOD GLUCOSE READING ABOVE 27.8 MMOL/L WILL READ AS A "HI" IN THE ADC METER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT A CUSTOMER'S METER WAS RECEIVING ERRATIC READINGS. CALLER REPORTED RECEIVING READINGS OF "HI" (GREATER THAN 27.8 MMOL/L), "HI" (GREATER THAN 27.8 MMOL/L) AND 1.6 MMOL/L WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" 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

    THE REPORT RECEIVED FROM THE FIELD STATES THAT WHEN ATTEMPTING TO CROSS THE LESION WITH THE STENT DELIVERY SYSTEM (SDS) THE STENT DISLODGED. THE AGE AND GENDER OF THE PATIENT ARE UNKNOWN. THE PROCEDURE WAS FOR TREATMENT OF A STENOSIS IN A PROXIMAL VEIN GRAFT. THE CHARACTERISTICS OF THE LESION ARE UNKNOWN. AS PER THE REPORT, THE PHYSICIAN DID NOT KNOW IF THE STENT WAS STILL ON THE BALLOON WHILE TRYING TO CROSS THE LESION. HE THEN PULLED BACK AND CHECKED THE STENT. THE PHYSICIAN THOUGHT THE STENT FELT STRANGE ON THE BALLOON CATHETER. A SECOND ATTEMPT WAS MADE TO CROSS THE LESION AND THIS IS WHEN THE STENT CAME OFF THE BALLOON. HE WENT IN WITH A 2.0 BALLOON AND SAVED THE STENT IN THE PROXIMAL VEIN GRAFT. THE STENT WAS SUCCESSFULLY DEPLOYED. NO PATIENT INJURY. THE PHYSICIAN'S CONCERN WAS WHY THIS HAPPENED - POSSIBLE STRUT BEING CAUGHT ON THE STENOSIS OR CAUGHT ON THE GUIDE. THE GUIDE USED WAS MEDTRONIC LAUNCHER JR 4 WITH OUTSIDE HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1067323

    Patients

    Seq Age Sex Outcome Treatment
    1