BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1953096 · Received January 7, 2011

    Report

    Report Number
    2954323-2011-00136
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 5, 2010
    Report Date
    February 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED. LOW BATTERY ICON WAS OBSERVED WITH THE RETURNED BATTERY THEREFORE BRAND NEW BATTERY WAS USED FOR TESTING. 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. IT SHOULD BE NOTED THAT PER CALLER, THE METER WAS "LEFT IN CAR AND IT WAS VERY COLD OUTSIDE. " THE LABEL COPY INDICATES "THE FREESTYLE FREEDOM LITE SYSTEM HAS AN OPERATING RANGE OF 40 TO 104 DEGREES FAHRENHEIT (4 TO 40 DEGREES CELSIUS). " ADDITIONALLY, DURING A TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, IT WAS IDENTIFIED THE CUSTOMER DID NOT ADD A SECOND DROP OF BLOOD TO THE TEST STRIP IN THE APPROPRIATE TIME FRAME AND THE CUSTOMER WAS EDUCATED HOW TO APPLY SECOND DROP OF BLOOD TO THE TEST STRIP IN THE APPROPRIATE TIME FRAME. THEY WERE ABLE TO SUCCESSFULLY PERFORM A TEST OVER THE PHONE.

    Description of Event or Problem · 1

    A CUSTOMER'S MOTHER REPORTED THE TEST WOULD NOT START AFTER SAMPLE WAS APPLIED AND AS A RESULT OF BEING UNABLE TO GET A READING, THE CUSTOMER BLINDLY SELF-DOSED WITH INSULIN BEFORE SHE WENT TO BED AND WAS FOUND UNCONSCIOUS NEXT MORNING. THE PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH A GLUCOSE INJECTION. THE CALLER ALSO REPORTED THAT AT THE TIME OF THE MEDICAL EVENT CUSTOMER'S BLOOD GLUCOSE WAS 35MG/DL, HOWEVER THE SOURCE OF THE READING IS UNKNOWN. 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 1075504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R