BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 14630472 · Received June 8, 2022

    Report

    Report Number
    3004464228-2022-09171
    Event Type
    Death
    Date Received
    June 8, 2022
    Date of Event
    May 22, 2022
    Report Date
    May 31, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000139
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED DEATH. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    A3 - GENDER CHANGED FROM NI TO FEMALE. D4 - MODEL NO CHANGED FROM PT-000010 TO 18320. D4 - CATALOG NO CHANGED FROM INT1-D001-MG TO BLE-I1-529. D4 - LOT NO CHANGED FROM 7540 TO BLANK. D4 - SERIAL NO CHANGED FROM (B)(6) TO BLANK. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). H4 - DEVICE MFG DATE CHANGED FROM 2/11/2021 TO BLANK. H6 - ADVERSE EVENT PROBLEM HEALTH EFFECT - CLINICAL CODE ADDED CODE FOR HYPERGLYCEMIA (E1205) AND COMPONENT CODE CHANGED FROM CONTROLLER TO PUMP (G04105). H8 - USAGE OF DEVICE CHANGED FROM REUSE TO INITIAL USE OF DEVICE.

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE PD FOUND NO ISSUES THAT WOULD HINDER THE DEVICE¿S ABILITY TO DELIVER INSULIN. DURING THE INVESTIGATION, A NEW UNUSED POD WAS PAIRED WITH THE PDM. A 5 UNIT TEST BOLUS WAS PROGRAMMED AND DELIVERED. NO ISSUES WERE FOUND. THE PDM WAS FOUND TO BE FUNCTIONING WITHIN SPECIFICATIONS. INSULET CONSIDERS THIS FILE TO BE CLOSED.D4 - MODEL NO CHANGED FROM 18320 TO PT-000010, D4 - CATALOG NO CHANGED FROM BLE-I1-529 TO INT1-D001-MG, D4 - LOT NO CHANGED FROM BLANK TO 7540, D4 - SERIAL NO CHANGED FROM BLANK TO (B)(6), D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO (B)(4), H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 2/11/2021, H6 - ADVERSE EVENT PROBLEM COMPONENT CODE CHANGED FROM PUMP TO CONTROLLER, H8 - USAGE OF DEVICE CHANGED FROM INITIAL USE OF DEVICE TO REUSE.

    Description of Event or Problem · 0

    ON MAY 31ST 2022, THE REPORTER INFORMED INSULET THAT A PATIENT HAD DIED WHILE USING THE OMNIPOD DASH SYSTEM. THE DEATH REPORTEDLY OCCURRED ON (B)(6) 2022 AT THE PATIENT¿S HOME; NO DEATH REPORT HAS BEEN PROVIDED AS OF TODAY¿S DATE. ACCORDING TO THE REPORTER, ON (B)(6), THE PATIENT WAS FEELING ILL AND WENT HOME FROM WORK EARLIER THAT DAY. THE REPORTER STATED THAT WHILE THE PATIENT WAS WEARING A POD (LOT NUMBER IS UNKNOWN) AT THE TIME OF PASSING, SHE WAS NOT WEARING HER CONTINUOUS BLOOD GLUCOSE (CGM) SENSORS SINCE (B)(6) 2022 AND SHE DID NOT MEASURE HER BLOOD GLUCOSE LEVELS WITH ANY OTHER DEVICE. THEREFORE, NO BLOOD GLUCOSE RESULTS ARE AVAILABLE AFTER THAT DATE. THE REPORTER STATED THE PATIENT HAD CHARCOT DISEASE AND DEPRESSION, TREATED BY ANTIDEPRESSANT. THE REPORTER PROVIDED THE BLOOD GLUCOSE LEVELS EXTRACTED FROM (B)(6) 2022 AND STATED THEY WERE ON AVERAGE AT 310 MG/DL WITH ONLY 1% OF LEVELS BEING OF HYPOGLYCEMIA. THE REPORTER STATED THE CGM EXTRACTION INDICATED THE ALARMS FOR HIGH AND LOW BLOOD GLUCOSE LEVELS (80 MG/DL AND 180 MG/DL) WERE CORRECTLY ACTIVATED ON THE CGM SYSTEM, INCLUDING A REMINDER EVERY 30 MINUTES FOR SEVERE LOW BLOOD GLUCOSE LEVELS AT 55 MG/DL. THE REPORTER EXTRACTED THE PDM DATA AND STATED THE BASAL RATES SET INTO THE OMNIPOD DASH PDM WERE UNCHANGED AND NO BOLUS DOSES WERE RECORDED AT MEAL TIMES OR AS CORRECTION DOSE. ACCORDING TO THE REPORTER, THE PATIENT WAS WORRIED ABOUT HAVING AN HYPOGLYCEMIC INCIDENT AND ONLY RARELY PROGRAMMED BOLUS DOSES. THE REPORTER STATED THIS WOULD CAUSE THE PATIENT¿S BLOOD GLUCOSE LEVELS TO REMAIN IN THE HIGH RANGE. THE REPORTER ALSO STATED THE PATIENT CHANGED THE POD EVERY 3 DAYS, AS PER INSTRUCTION FOR USE. THE REPORTER STATED THE PDM (SN (B)(4)) AND THE POD USED AT THE TIME OF THE PATIENT¿S DEATH ARE BEING KEPT WITH THE POLICE ((B)(6)) DURING THE INVESTIGATION. ACCORDING TO THE REPORTER, THE DEVICES WILL BE RETURNED TO THEM BY THE POLICE AFTER THE INVESTIGATION IS COMPLETE, AND THE REPORTER WILL RETURN THE DEVICES TO INSULET FOR INVESTIGATION. THE REPORTER WAS NOT INFORMED OF WHEN THE POLICE INVESTIGATION WOULD BE CLOSED. INSULET WILL SUBMIT TO THE (B)(6) A SUPPLEMENTAL REPORT ON OR BEFORE AUGUST 6TH 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158818 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000010 7540 10385082000139

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death