BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2013845 · Received March 10, 2011

    Report

    Report Number
    2954323-2011-02151
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 20, 2011
    Report Date
    April 20, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED ON RETURNED METER (B)(4) AND RETAINED TEST STRIPS LOT NUMBER 1017514. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. 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 ON (B)(6), 2011 SHE RECEIVED A MESSAGE "HI" ON THE SCREEN OF THEIR FREESTYLE LITE METER AND SELF-DOSED WITH INSULIN. THE CUSTOMER REPORTEDLY EXPERIENCED HEADACHE, NUMBNESS IN THE LEFT SIDE OF BODY AND SEIZURE AND SELF-TREATED WITH ANTI-ANXIETY MEDICATION XANAX TO COUNTERACT THE EVENT. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1084527

    Patients

    Seq Age Sex Outcome Treatment
    1 Other