BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 5144693 · Received October 13, 2015

    Report

    Report Number
    3004753838-2015-81591
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 17, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)4(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. THE COMPLAINT STATES THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT ON (B)(6) 2015, RESULTING IN MEDICAL INTERVENTION. IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON 09/17/2015, TO REPORT A HYPOGLYCEMIC EVENT ON (B)(6) 2015, REQUIRING MEDICAL INTERVENTION. PATIENT STATED DEXCOM CONTINUOUS GLUCOSE MONITOR (CGM) ALERTED HIM OF THE LOW BLOOD GLUCOSE LEVEL. PATIENT PERFORMED FINGER STICK BLOOD GLUCOSE (BG) TEST TO CONFIRM THE LOW. PATIENT DOES NOT RECALL WHAT THE VALUES WERE. PATIENT CALLED FOR AN AMBULANCE. PATIENT WAS GIVEN GLUCAGON BY THE EMERGENCY MEDICAL TECHNICIAN'S (EMT). NO FURTHER TREATMENT WAS GIVEN, BUT PATIENT WAS TAKEN TO THE HOSPITAL. PATIENT REPORTED THAT DUE TO BASAL METABOLIC RATE (BMR) LOWERING, A BLOOD PRESSURE READING AT 90 SYSTOLIC OVER 60 DIASTOLIC, AND SELF-MEDICATING WITH ALCOHOL FOR 2 WEEKS, HE WAS TAKEN TO THE HOSPITAL FOR OBSERVATION. PATIENT REPORTED THE EVENT WAS NOT RELATED TO CGM OR PUMP. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. AT THE TIME OF CONTACT, PATIENT REPORTED THAT HE WAS AT HOME RECOVERING. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675684 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. MT20649-BLU 5196973

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other