BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3041453 · Received April 8, 2013

    Report

    Report Number
    2954323-2013-00196
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. ADDITIONALLY, THE SERIAL NUMBER OF THE METER IS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY ONE MONTH PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6) 2013, SHE RECEIVED A READING OF 166 MG/DL ON HER ADC BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN A SUBSEQUENT READING OF 66 MG/DL RECEIVED BY A PARAMEDIC. CUSTOMER FURTHER REPORTED THAT AFTER RECEIVING THE READING OF 166 MG/DL, SHE WENT TO THE GROCERY STORE BUT THEN EXPERIENCED A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND UPON ARRIVAL OBTAINED A READING OF 66 MG/DL ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS GIVEN A GLUCOSE TABLET AND REFUSED TRANSPORT TO A HEALTHCARE FACILITY. NO SELF-TREATMENT WAS REPORTED. IT IS UNKNOWN PRECISELY HOW MUCH TIME HAD ELAPSED BETWEEN THE TWO READINGS. CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING, SO NO FURTHER INFORMATION WILL BE AVAILABLE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142837 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R