BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2912280 · Received January 11, 2013

    Report

    Report Number
    2954323-2013-00012
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 2, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. NOTE: THE METER'S MANUFACTURE DATE IS UNKNOWN, THE MANUFACTURE DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT. CUSTOMER STATED THAT SHE HAS 8 ADC METERS AND IS UNSURE ABOUT WHICH METER THE READING OF 5.2 MMOL/L WAS TAKEN ON.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2012 AT AROUND 10 AM (EXACT DATE AND TIME UNKNOWN) SHE RECEIVED A READING OF 5.2 MMOL/L (94 MG/DL) ON HER ADC METER THAT WAS HIGHER THAT SHE FELT. IT WAS FURTHER REPORTED THAT CUSTOMER HAD EXPERIENCED A LOSS OF CONSCIOUSNESS. CUSTOMER NOTED THAT SHE "DID NOT FEEL LOW, BUT PARTNER HAD THOUGHT SHE WAS GOING LOW AS (CUSTOMER) WAS SWEATING, THEN SHE PASSED OUT". CUSTOMER WAS TREATED BY HER PARTNER WITH GLUCAGON INJECTION AND LUCOZADE AND "DID NOT COME AROUND UNTIL 14:00 HOURS". 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
    17814 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R