BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3011567 · Received March 19, 2013

    Report

    Report Number
    2954323-2013-00162
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 21, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. MULTIPLE, UNSUCCESSFUL, ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED THAT ON (B)(6) 2013 CUSTOMER WAS ABOUT TO PERFORM A TEST USING HER ADC BLOOD GLUCOSE METER, BUT THEN NOTICED THE DATE AND TIME WERE NOT CORRECT. CUSTOMER THEN EXPERIENCED A LOSS OF CONSCIOUSNESS. IT IS UNKNOWN IF THE CUSTOMER ACTUALLY RECEIVED A READING FROM THE METER PRIOR TO HER LOSS OF CONSCIOUSNESS. CUSTOMER DENIED SELF-TREATING. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY. CALLER DID NOT KNOW WHAT, IF ANY, SERVICES THEY PERFORMED BEYOND TRANSPORT. AT THE HEALTHCARE FACILITY, CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND INSULIN. CALLER INDICATED CUSTOMER WAS ALSO GIVEN A NOVOLOG FLEX PEN. CUSTOMER WAS HOSPITALIZED FOR FOUR DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114448 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O| R