BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3909061 · Received July 2, 2014

    Report

    Report Number
    2954323-2014-00745
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 10, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. DATE ENTERED IS REFLECTIVE OF THE CUSTOMER REPORTING THE EVENT OCCURRED IN (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. THE 510(K) OF THE INITAIL REPORT IS INCORRECT. SECTION POPULATED WITH K092638, CORRECT 510(K) # IS K092602.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT IN (B)(6) HER ADC BLOOD GLUCOSE METER WAS UNRESPONSIVE WHEN BOTH BUTTONS WERE PRESSED AND SHE WAS THEREFORE UNABLE TO TEST. CUSTOMER FURTHER REPORTED SHE BELIEVED HER BLOOD GLUCOSE WAS LOW AND STATED SHE EXPERIENCED A SEIZURE. CUSTOMER WAS REPORTEDLY TREATED BY A NON-HCP WITH UNSPECIFIED MEDICATION FOR SEIZURE AND A GLUCAGON INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386751 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other| R