BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1213710 · Received October 24, 2008

    Report

    Report Number
    2954323-2008-02774
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 24, 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. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHE RECEIVED A READING OF 154 MG/DL ON HER METER BEFORE SHE ATE NOODLES FOR LUNCH AT 2:30 AND TOOK HER REGULAR DOSE OF 35 UNITS OF NOVALOG. AT APPROXIMATELY 5:45PM, AS SHE WAS DRIVING HOME HER EYES WERE BLURRY AGAIN AND SHE WAS SWEATING PROFUSELY, SHE TOOK A READING OF 112 MG/DL AT THAT TIME. SHE PHONED HER HUSBAND TO LET HIM KNOW HOW SHE FELT AND FINISHED DRIVING HOME. WHEN SHE ARRIVED HOME ABOUT 11 MINUTES LATER, SHE SAID SHE PASSED OUT AND HER HUSBAND GOT A READING OF 117 MG/DL ON THEIR METER. HE DROVE HER TO THE HOSPITAL ABOUT 20 MINUTES AWAY AND WAS RUSHED INTO THE NURSES. THE NURSE TOOK A BLOOD GLUCOSE OF 35 MG/DL AND GAVE HER ORANGE JUICE AND IV OF AN UNKNOWN SOLUTION. SHE SAID THEY ALSO GAVE HER A GLASS OF MILK. SHE DOES NOT REMEMBER A DIAGNOSIS. SHE STAYED ONLY A FEW HOURS AT THAT TIME AND WAS RELEASED. THE DOCTORS DID NOT CHANGE HER MEDICATIONS AT THE TIME, BUT THAT SHE HAS AN APPOINTMENT TO SEE HER ENDOCRINOLOGIST. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention