BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2133018 · Received June 17, 2011

    Report

    Report Number
    2954323-2011-03598
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 29, 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER POWERED ON WITH BUTTON PRESS AND STRIP INSERTION. DID NOT OBSERVE POWER ISSUE WITH STRIP PORT. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER TURNS ON WHEN THE BUTTON IS PRESSED, BUT NOT WITH TEST STRIP INSERTION. HE FURTHER REPORTED THAT ON (B)(6) 2011 HIS WIFE TRIED TO WAKE HIM UP, BUT COULD NOT. HE FURTHER REPORTED EXPERIENCING TREMULOUSNESS, DISORIENTATION AND DIAPHORESIS. PARAMEDICS WERE CALLED, ADMINISTERED A "GLUCOSE" INJECTION AND AN INTRAVENOUS INFUSION OF UNKNOWN TYPE. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA. IT IS UNKNOWN WHAT ADDITIONAL TREATMENT MAY HAVE BEEN RENDERED. CUSTOMER DENIED SELF-TREATING. 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 1029104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R