BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2112099 · Received June 2, 2011

    Report

    Report Number
    2954323-2011-03475
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 2, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE MEDICAL EVENT WAS RELATED TO THE CUSTOMER USING INCOMPATIBLE TEST STRIPS, HENCE THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THEREFORE NO INVESTIGATION OF THE PRODUCT IS REQUIRED. IT SHOULD BE NOTED: WHILE TROUBLESHOOTING WITH CUSTOMER SERVICE IT WAS REVEALED THE CUSTOMER WAS ATTEMPTING TO TEST USING INCOMPATIBLE TEST STRIPS (FREESTYLE CLASSIC) THAT WERE EXPIRED (EXP: (B)(6) 2010).

    Description of Event or Problem · 1

    A CUSTOMER'S FRIEND REPORTED A PORT ISSUE (CUSTOMER HAD INCOMPATIBLE TEST STRIPS, BUT WAS UNAWARE OF IT), INVOLVING CUSTOMER'S FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. CALLER FURTHER REPORTED THAT BECAUSE OF THIS CUSTOMER WAS UNABLE TO TEST AND SUBSEQUENTLY EXPERIENCED VERTIGO, TREMULOUSNESS, NAUSEA AND FELT DROWSY. PARAMEDICS WERE CALLED AND PROVIDED CUSTOMER WITH OXYGEN AND A BAYER ASPIRIN. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN AND AN INTRAVENOUS INFUSION OF UNKNOWN TYPE. CUSTOMER REMAINED IN THE HOSPITAL OVERNIGHT. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0832940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R