BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1994015 · Received February 16, 2011

    Report

    Report Number
    2954323-2011-01655
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    March 17, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN RETURNED AND INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE METER IS DESIGNED TO REPORT READINGS OF 20 MG/DL TO 500 MG/DL. IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS GREATER THAN 500 MG/DL. A READING GREATER THAN 500 MG/DL WOULD DISPLAY A "HI" MESSAGE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE BEGAN GETTING HIGHER THAN FEELS READINGS AROUND (B)(6), 2010 AND RECEIVED MESSAGE "HI" ON SEVERAL OCCASIONS. THE CUSTOMER FURTHER REPORTED TO INTERMITTENTLY EXPERIENCING TIREDNESS, DIAPHORESIS, WEAKNESS AND COLD. SHE ALSO REPORTEDLY LOST CONSCIOUSNESS AFTER TAKING AN UNSPECIFIED SLEEPING PILL. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1001304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other