BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2141772 · Received June 27, 2011

    Report

    Report Number
    2954323-2011-03684
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 3, 2011
    Report Date
    August 23, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT SHOULD BE NOTED: WHILE TROUBLESHOOTING WITH CUSTOMER SERVICE IT WAS REVEALED THE CUSTOMER WAS ATTEMPTING TO TEST USING INCORRECT TEST STRIPS; FREESTYLE LITE TEST STRIPS INSTEAD OF FREESTYLE CLASSIC TEST STRIPS.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    A CUSTOMER CALLED ON (B)(6), 2011 AND REPORTED THAT BEGINNING IN MAY HE STARTED RECEIVING READINGS FROM HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER THAT WERE LOWER THAN HE WAS FEELING. HE FIRST NOTICED THIS AFTER RECEIVING A READING OF 136 MG/DL ON (B)(6), 2011, WHICH WAS LOWER THAN HE FELT AT THE TIME. HE ALSO REPORTED THAT ON (B)(6), 2011 HE RECEIVED A READING OF 155 MG/DL, BUT NOTED THAT APPROXIMATELY 25-30 MINUTES LATER HIS HEALTHCARE PROVIDER RECEIVED A READING, ON AN UNKNOWN BRAND OF METER, OF 325 MG/DL. CUSTOMER REPORTED EXPERIENCING FATIGUE, BLURRED VISION AND POLYURIA AND WAS DIAGNOSED WITH HYPERGLYCEMIA. CUSTOMER WAS GIVEN THE FOLLOWING MEDICATIONS, WHICH WERE A CHANGE FROM HIS USUAL DIABETES TREATMENT REGIMEN: GLIMEPERIDE, GLUCOTROL AND ACTOS. CUSTOMER WAS ALSO DIAGNOSED WITH NEUROPATHY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1075903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention