BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1172062 · Received September 23, 2008

    Report

    Report Number
    2954323-2008-02609
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 24, 2008
    Report Date
    September 23, 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. PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ADC METER READING OF 70 MG/DL THAT THEY STATE WAS "LOWER" THAN THEY FELT, YET HE EXPERIENCED SYMPTOMS OF SWEATINESS, SHAKINESS, THIRST, "NOT MAKING SENSE" AND BEING "CLOSE TO HAVING LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND RECEIVED A METER READING OF 43 MG/DL. IT IS UNK WHAT METER WAS USED TO OBTAIN THE SECOND READING. THE CUSTOMER STATED HE WAS "INJECTED WITH GLUCOSE" BY PARAMEDICS AND TRANSFERRED TO A LOCAL HOSPITAL. HE WAS DIAGNOSED WITH HYPOGLYCEMIA, TREATED BY A DOCTOR AND "INJECTED" WITH GLUCOSE "THREE (MORE) TIMES". HE WAS ALSO GIVEN AN IV (SOLUTION UNK) AND ADMITTED FOR 24 HOUR OBSERVATION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0633821

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention