BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6295329 · Received February 1, 2017

    Report

    Report Number
    3004753838-2017-01145
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 5, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Description of Event or Problem · 1

    A RECEIVER (PART NUMBER STR-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5220680) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THERE WAS NO ALLEGED MALFUNCTION TO THE DEVICE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 01/05/2017, THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. THE PATIENT STATED THAT HE WAS SOUND ASLEEP AND HIS WIFE HEARD HIM TALKING NON SENSE IN HIS SLEEP. THE PATIENT'S WIFE WOKE THE PATIENT UP AND HE WOULD NOT EAT ANYTHING AND NOT REALLY RESPONDING. THE PATIENT'S WIFE CALLED EMERGENCY MEDICAL TEAMS (EMT) ON (B)(6) 2017 AND THEY CAME AT 5:30AM. THE EMT TEAM SHOT THE PATIENT WITH GLUCAGON AFTER CHECKING HIS BLOOD SUGAR, WHICH WAS AT 23MG/DL. AFTER A LITTLE WHILE THE PATIENT FELT BETTER AND REFUSED TO GO TO HOSPITAL BEFORE EMT LEFT THE PATIENT'S BLOOD SUGAR WAS AT 70MG/DL. NO PRODUCT DEFECTS OR FAILURES WERE ALLEGED. AT TIME OF CONTACT THE PATIENT'S CONDITION WAS FAIR. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76859 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR MDS DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other