BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 16482259 · Received March 3, 2023

    Report

    Report Number
    3004464228-2023-06077
    Event Type
    Death
    Date Received
    March 3, 2023
    Date of Event
    July 27, 2022
    Report Date
    February 6, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]..), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. [1] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. [1] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.

    Description of Event or Problem · 0

    IN RESPONSE TO RECEIVING A LETTER REGARDING ACTIONS RELATED TO THE DASH OMNIPOD SYSTEM, THE PATIENT¿S SON CONTACTED INSULET TO REPORT THAT THE PATIENT HAD EXPIRED. THE PATIENT WAS ADMITTED TO A LOCAL HOSPITAL APPROXIMATELY ON (B)(6) 2022, WAS TRANSFERRED TO A SECOND FACILITY WHERE HE SUCCUMBED TO HIS ILLNESS AND EXPIRED ON (B)(6) 2022. THE PATIENT IS NOTED TO HAVE THE FOLLOWING COMORBIDITIES: DIABETES, DEMENTIA, HEART DISEASE AND RESPIRATORY FAILURE. IT IS UNKNOWN IF THE OMNIPOD SYSTEM WAS IN USE AT THE TIME OF HIS DEATH. THE POD AND PDM ARE NOT EXPECTED TO BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE CASE WILL BE REOPENED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913946 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 UNAVAILABLE 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death