BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3170417 · Received June 14, 2013

    Report

    Report Number
    2954323-2013-00339
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 16, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAIN TEST STRIPS. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING OF 134 MG/DL ON HER ADC METER ON (B)(6) 2013 AT AROUND 10 PM WHICH WAS LOWER THAN SHE FELT. IT WAS FURTHER REPORTED THAT LATER ON (B)(6) 2013 CUSTOMER HAD A LOSS OF CONSCIOUSNESS AND WAS FOUND BY HER HUSBAND WHO GAVE CUSTOMER SUGAR ORALLY AND ADMINISTERED 1 MG OF GLUCOPHAGE VIA INJECTION (CUSTOMER INITIALLY STATED IT WAS GLUCAGON, THEN CHANGED THE ANSWER TO GLUCOPHAGE). PARAMEDICS WERE CALLER AND IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED, HOWEVER, NO OTHER INFORMATION IS AVAILABLE. 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
    270688 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R