BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1891375 · Received November 4, 2010

    Report

    Report Number
    2954323-2010-01521
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    December 29, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. ADDITIONALLY, CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS METER. CUSTOMER REPORTED RECEIVING READINGS OF 269 MG/DL AND 142 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES IS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT. IT IS UNKNOWN WHEN THIS COMPARISON WAS DONE RELATIVE TO THE REPORTED MEDICAL EVENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4) AND STRIP LOT NUMBER 1015930. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, THE READING REPORTED WAS NOT FOUND IN THE INTERNAL MEMORY LOG OF THE METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2010, HE RECEIVED A READING OF 400 MG/DL ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER AND SELF-ADMINISTERED AN UNKNOWN AMOUNT OF NOVOLOG INSULIN. CUSTOMER ATE BREAKFAST AND THEN WENT TO PLAY GOLF, BUT BEGAN TO EXPERIENCE VERTIGO, ATAXIA AND CONFUSION, RESULTING IN A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED, CHECKED HIS GLUCOSE ON AN UNKNOWN BRAND OF METER AND RECEIVED A RESULT OF 40 MG/DL. AN INTRAVENOUS INFUSION OF UNKNOWN TYPE WAS INITIATED AND THE CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. CUSTOMER WAS UNABLE TO REPORT WHAT TREATMENT WAS GIVEN AT THE HOSPITAL, BUT NOTED THEY GAVE HIM A SANDWICH TO EAT AFTER HE REGAINED CONSCIOUSNESS. CUSTOMER ALSO REPORTED THAT "A COUPLE OF WEEKS AGO" WHILE AT HIS WIFE'S FUNERAL HE SELF-ADMINISTERED NOVOLOG INSULIN AND SUBSEQUENTLY EXPERIENCED VERTIGO, CONFUSION AND ATAXIA RESULTING IN A LOSS OF CONSCIOUSNESS. THE CUSTOMER'S GRANDDAUGHTER CHECKED HIS GLUCOSE, RECEIVED A RESULT "AROUND 40 MG/DL" AND "HELPED TO BRING HIM TO". IT IS UNKNOWN WHETHER HE CHECKED HIS GLUCOSE PRIOR TO THE INSULIN IN THE EVENT THAT OCCURRED AT THE FUNERAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THESE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER I.V. THERAPY REPRESENTATIVE A CLEARLINK CATHETER EXTENSION SET IN WHICH THE PROXIMAL END OF THE SET BECAME DETACHED FROM THE TUBING AND CAUSED THE PATIENT TO BLEED SLIGHTLY. THE INCIDENT OCCURRED IN THE ICU. NO ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1015930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R