BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1822119 · Received September 1, 2010

    Report

    Report Number
    2954323-2010-01210
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    October 5, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION WILL BE UNDERTAKEN UPON RECEIPT OF THE CUSTOMER'S PRODUCTS. A FINAL REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER 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.

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED THAT ON (B)(6) 2010 CUSTOMER BECAME UNCONSCIOUS WHILE SHE WAS SLEEPING AND SUBSEQUENTLY EXPERIENCED A SEIZURE. PARAMEDICS WERE CALLED. IT WAS FURTHER REPORTED A READING OF 60 MG/DL WAS RECEIVED ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER WHICH WAS HIGHER WHEN COMPARED TO A RESULT OF 20 MG/DL OBTAINED ON AN UNKNOWN BRAND OF METER BY A HEALTHCARE PROFESSIONAL. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH POTASSIUM AND "HYDRATION FOR HER SWEATING". CUSTOMER'S HUSBAND ALSO THOUGHT CUSTOMER MAY HAVE BEEN GIVEN SOMETHING TO BRING UP HER GLUCOSE, BUT DID NOT KNOW EXACTLY WHAT IT WAS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 4.43 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO AORTIC REGURGITATION AND PERIVALVULAR LEAK, SECONDARY TO ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0936315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R