BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18678463 · Received February 9, 2024

    Report

    Report Number
    3004753838-2024-035297
    Event Type
    Death
    Date Received
    February 9, 2024
    Date of Event
    December 1, 2023
    Report Date
    February 9, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VOLUNTARY MEDWATCH REPORT NUMBER MW5149947DIABETES MELLITUS IS A KNOWN CAUSE DIABETIC KETOACIDOSIS.H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH REPORT (MW5149947) THAT ¿A 76 YEAR OLD WOMAN WITH DECADES OF EXPERIENCE LIVING WITH DIABETES 1 DIED FROM DKA (DIABETIC KETOACIDOSIS) ON OMNIPOD 5 INSULIN PUMP AND DEXCOM CGM (CONTINUOUS GLUCOSE MONITORING). SHE DEVELOPED DKA WITHIN HOURS OR REPLACING HER OMNIPOD 5 AND DEXCOM CGM SENSOR WITH SENSOR MALFUNCTION AND INSULIN PUMP MALFUNCTION NOTED ON (B)(6) BY POSTHUMOUS DOWNLOAD AND REVIEW OF DATA FROM (B)(6) AFTER SHE WAS DISCOVERED DEAD IN HER BED (B)(6) 2023. DEATH REPORTED (B)(6) (FOUND COLD IN BED). LAST CONTACT WITH ANY PERSON (B)(6) MORNING WITH THIRD PARTY REPORT OF VOMITING OVERNIGHT. LAST KNOWN ACTION OF ANY KIND (B)(6) WITHIN 2 HOURS OF INSULIN BOLUS. ALL PHYSICIANS AND DIABETES CARE TEAM MEMBERS CONCLUDED UNANIMOUSLY CAUSE OF DEATH WAS FROM DKA FROM LACK OF INSULIN AFTER CHANGE IN INSULIN POD AND SENSOR MALFUNCTION. PATIENT HAD VISION PROBLEMS.¿ DEXCOM FOLLOWED UP WITH THE COMPLAINT REPORTER AND THEY CLARIFIED EVENT DATES, HOWEVER THEY DID NOT PROVIDE ANY PATIENT IDENTIFIABLE INFORMATION, BUT PLANNED TO CONTACT THE PATIENT'S FAMILY TO OBTAIN CONSENT FOR RELEASE OF INFORMATION. THE REPORTER STATED THE PATIENT USED A GLUCOMETER AT SOME POINT DURING THE EVENT, THE REPORTER COULD NOT RULE OUT THAT A CGM AND PUMP COMMUNICATION ISSUE MAY HAVE CONTRIBUTED TO THE DKA AT HOME BETWEEN (B)(6) AND (B)(6) 2023 WHICH LED TO THE PATIENT'S DEATH ON (B)(6) 2023. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. AS OF (B)(6) 2024, NO IDENTIFIABLE PATIENT INFORMATION IS AVAILABLE. IF ADDITIONAL PATIENT OR EVENT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52240 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death| O OMNIPOD 5 INSULIN PUMP