BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 INSULIN PUMP

    MDR report key: 18474982 · Received January 8, 2024

    Report

    Report Number
    MW5149946
    Event Type
    Death
    Date Received
    January 8, 2024
    Date of Event
    December 1, 2023
    Report Date
    January 5, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 76 YEAR OLD WOMAN WITH DECADES OF EXPERIENCE LIVING WITH DIABETES 1 DIED FROM DKA ON OMNIPOD 5 INSULIN PUMP AND DEXCOM CGM (CONTINUOUS GLUCOSE MONITORING). SHE DEVELOPED DKA (DIABETIC KETOACIDOSIS) 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. REF REPORT: MW5149947.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650577 OMNIPOD 5 INSULIN PUMP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death DEXCOM CONTINUOUS GLUCOSE MONITOR