BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1840346 · Received September 21, 2010

    Report

    Report Number
    2954323-2010-01309
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 26, 2010
    Report Date
    October 19, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    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 FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THAT ON (B)(6), 2010 AT 7:50 PM CUSTOMER CHECKED HIS GLUCOSE USING HIS FREESTYLE BLOOD GLUCOSE METER AND RECEIVED A RESULT OF 153 MG/DL. SHE FURTHER REPORTED HE THEN SELF-ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN (TYPE OF INSULIN WAS NOT PROVIDED) AND ATE DINNER. CUSTOMER WENT TO SLEEP AT APPROXIMATELY 10:00 PM. A "COUPLE OF HOURS" LATER HIS WIFE WAS UNABLE TO AWAKEN HIM, CALLED THE PARAMEDICS AND WHILE ON THE PHONE RE-CHECKED HIS GLUCOSE AND RECEIVED A RESULT OF 147 MG/DL. THE PARAMEDICS ARRIVED AND WITHIN 10 MINUTES OF HIS RESULT, THEY RECEIVED A READING OF 40 MG/DL, ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS GIVEN AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND ALSO SELF-TREATED WITH FOOD AND JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN SLITTING THE 90 DEGREE SUBSELECTION CATHETER, THE HUB SECTION CAME OFF LEAVING THE SUBSELECTION CATHETER IN THE PATIENT, UNABLE TO BE SLIT. THE LV LEAD (4196) WAS REMOVED WITH REMAINING SUBSELECTION CATHETER. IT WAS ALSO REPORTED THAT THE LV LEAD WAS REPOSITIONED WITHOUT THE SUBSELECTION CATHETER, RESULTING IN A LONGER PROCEDURE AND X-RAY EXPOSURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 0932319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R