BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5926720 · Received September 2, 2016

    Report

    Report Number
    3004753838-2016-80174
    Event Type
    Death
    Date Received
    September 2, 2016
    Date of Event
    July 29, 2016
    Report Date
    August 8, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A RECEIVER (SERIAL NUMBER (B)(4)/LOT NUMBER 5213258) WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS. ADDITIONALLY, A TRANSMITTER (SERIAL NUMBER (B)(4)/LOT NUMBER 5212248) WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING AND A PAIRING TEST WAS PERFORMED AND THE TESTS PASSED. BOTH THE RECEIVER AND TRANSMITTER WERE DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THERE WAS NO ALLEGED MALFUNCTIONS REPORTED ON THE DEVICES THAT WERE RETURNED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 08/08/2016 THAT THE PATIENT PASSED AWAY ON (B)(6) 2016. ON THE NIGHT OF FRIDAY (B)(6) 2016, THE PATIENT WOKE WITH SEVERE VOMITING. AFTER SOMETIME, THE PATIENT RECALLED A SIMILAR FEELING AND INSTRUCTED HER HUSBAND TO CALL 911. EMERGENCY MEDICAL TECHNICIANS (EMTS) WERE DISPATCHED EARLY SATURDAY MORNING, (B)(6) 2016. EMTS TOOK THE PATIENT'S BLOOD PRESSURE AND BLOOD GLUCOSE AND RUSHED HER TO THE MEDICAL CENTER. WHEN THE PATIENT ARRIVED THEY WERE TACHYPNEA AND TACHYCARDIA WITH HYPOTENSION. THE PATIENT WAS GIVEN CAT-SCAN AND MRI TO EVALUATE OBSTRUCTION HOWEVER, THE PATIENT NEVER BECAME STABLE ENOUGH FOR TREATMENT AND DIED AT APPROXIMATELY 3:05AM (B)(6) 2016. THE CAUSE OF DEATH WAS REPORTED AS PYELONEPHRITIS. A CERTIFICATE OF DEATH WAS NOT PROVIDED. PATIENT WAS NOT WEARING THE CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH, AS IT HAD BEEN REMOVED WHILE IN THE HOSPITAL ON (B)(6) 2016. THERE WAS NO ALLEGED DEVICE MALFUNCTION. ADDITIONAL EVENT OR PATIENT INFORMATION WAS NOT PROVIDED. NO PRODUCT OR DATA WAS RETURNED FOR INVESTIGATION. A CERTIFICATE OF DEATH WAS NOT PROVIDED. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575851 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H| O