BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1060678 · Received June 13, 2008

    Report

    Report Number
    2954323-2008-02115
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 6, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED HIS METER. DEVICE EVALUATION ON THE RETURNED METER DID NOT CONFIRM THE READING HIGH COMPLAINT AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. IT IS UNKNOWN WHEN THE CUSTOMER HAD THE MEDICAL EVENT. THE METER MEMORY LOG SHOWS THAT THE NIGHT BEFORE THE EVENT, AT 9:46 PM, THE CUSTOMER HAD A LOW READING OF 68 MG/DL. ON THE FOLLOWING DAY, (DAY OF THE EVENT), THE CUSTOMER HAD ANOTHER LOW READING OF 70 MG/DL AT 5:06 AM. THE METER MEMORY LOG ALSO SHOWS A READING OF 424 MG/DL THE FOLLOWING DAY, AT 2:07 PM.

    Description of Event or Problem · 1

    A CUSTOMER CALLED ADC CUSTOMER SERVICE ON 17MAY2008 AND REPORTED THAT IN 2008, HE LOST CONSCIOUSNESS, FELL ON THE FLOOR AND BROKE FOUR RIBS BECAUSE HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER WAS REPORTEDLY HIGH WHEN THE BLOOD GLUCOSE WAS LOW. ADDITIONALLY, THE CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF NUMBNESS IN HIS LIPS AND SWEATINESS. THE PARAMEDICS WERE CALLED AND TRANSPORTED HIM TO THE HOSPITAL WHERE HE WAS REPORTEDLY DIAGNOSED WITH SEVERE HYPOGLYCEMIA, BUT HE COULD NOT REPORTEDLY REMEMBER THE TREATMENT HE HAD IN THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0806527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| R