BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1172057 · Received September 22, 2008

    Report

    Report Number
    2954323-2008-02586
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A METER READING OF 77 MG/DL ON HIS ADC METER AND LOST CONSCIOUSNESS IMMEDIATELY AFTER TESTING. HIS WIFE CALLED PARAMEDICS AND UPON ARRIVAL GOT A GLUCOSE READING OF 37 MG/DL ON THEIR HCP METER, STARTED AN IV (SOLUTION UNK) AND GAVE HIM ORANGE JUICE. HE WAS ASKED IF HE WANTED TO BE TRANSPORTED TO A HOSP OR BE SEEN BY HIS DOCTOR. CUSTOMER CHOSE TO BE SEEN BY HIS PHYSICIAN. HIS PHYSICIAN DIAGNOSED HIM WITH HYPOGLYCEMIA AND ADJUSTED HIS INSULIN DOSAGE, HOWEVER, NO TREATMENT WAS RENDERED DURING HIS PHYSICIAN APPOINTMENT. HE ALSO REPORTED EATING FOOD AND DRINKING JUICE TO HELP ALLEVIATE HIS SYMPTOMS. 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 BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0815221

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention