BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1792179 · Received August 10, 2010

    Report

    Report Number
    2954323-2010-01097
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 17, 2010
    Report Date
    September 3, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT WAS 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 WAS NOT FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SERIOUS BRAIN DAMAGE OCCURRED DURING AN ABLATION PROCEDURE, THE CASE WAS STOPPED AND THE PATIENT NEEDED ICU TREATMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PROCEDURE (ATRIAL FIBRILLATION) TOOK PLACE ON (B)(6)2010. DURING THE PROCEDURE, THE CUSTOMER NOTICED A RISE IN IMPEDANCE AND CHECKED THE CATHETER AND FOUND A LITTLE CHARRING. THEY REMOVED THE CHARRING, CHECKED THE CATHETER FLOW, AND CONTINUED THE PROCEDURE WITH THE SAME CATHETER AS EVERYTHING SEEMED NORMAL. THE SETTINGS USED FOR ABLATION WERE: 48 DEGREES CELSIUS, 50 WATT, AND LONG ABLATION TIME OF 999 SECONDS OR ABOVE (DRAG AND DROP METHOD). TOWARDS THE END OF THE CASE, WHEN TRYING TO AWAKEN THE PATIENT, THE PATIENT PRESENTED DIFFICULTY BREATHING AND WAS SENT TO THE ICU, THEN TO A NEUROLOGICAL HOSPITAL. IMMEDIATE CT SCAN DID NOT REVEAL ANYTHING, BUT MRI PERFORMED BY A NEUROLOGIST REVEALED MULTIPLE EMBOLI. THE PATIENT HAD A CONTRACT NOT TO USE LIFE SUSTAINABLE DEVICES, SO THESE WERE STOPPED AND THE PATIENT DIED ON (B)(6)2010. NO POST-MORTEM WILL BE PERFORMED. THE PATIENT HAD ARTERIAL HYPERTENSION AND WAS A SMOKER, BUT SHE DID NOT HAVE CORONARY ARTERY DISEASE, HEART FAILURE, DIABETES, OR HISTORY OF STROKE. THE HOSPITAL CONTACT (PHYSICIAN) STATED THAT THE REASONS FOR THE PATIENT'S DEATH ARE STILL UNCLEAR, BUT THOUGHT THAT MULTIPLE THROMBOEMBOLIC EVENTS DIRECTLY CONTRIBUTED TO THE PATIENT'S DEATH. HE THOUGHT THAT THE EVENT WAS PROCEDURE-RELATED AND POSSIBLE PRODUCT-RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING AN ERROR-3 MESSAGE ON THEIR FREESTYLE FREEDOM LITE METER AND AS A RESULT OF BEING UNABLE TO TEST, HER BLOOD SUGAR DROPPED TO 42 MG/DL (REPORTEDLY OBTAINED ON HER ADC METER) , WHICH RESULTED IN A HYPOGLYCEMIC EPISODE WITH LOSS OF CONSCIOUSNESS AND SEIZURE. THE CUSTOMER FURTHER REPORTED HER HUSBAND DROVE HER TO A LOCAL HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH GLUCOSE INTRAVENOUS INFUSION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R