BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 20176958 · Received September 9, 2024

    Report

    Report Number
    3004464228-2024-32345
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 11, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000139
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INSULET HAD A FOLLOW-UP CALL WITH THE PATIENT'S HEALTH CARE PROFESSIONAL WHO CONFIRMED THAT THE PATIENT HAD DECEASED. HE INDICATED TO THAT HE BELIEVED IT WAS INTENTIONAL AND THE PATIENT COMMITTED SUICIDE. THE PDM DATA LOG DID NOT INDICATE ANY MALFUNCTION OF THE DEVICE AND INSULET CONCLUDES IT WAS FUNCTIONING AS INTENDED. THE CHANGE OF THE BASAL MAXIMUM RATE AND BASAL RATE OCCURRED MANUALLY (USER OPERATION). THE PDM LOG RECORDED 3 DIFFERENT BOLUS DOSES WERE PROGRAMMED AFTER THE BASAL RATE OF 15U/H WAS PROGRAMMED, AND 2 PODS WERE ACTIVATED AFTER THE RESERVOIR WAS EMPTIED ON EACH POD AND AN ¿EXPIRED POD¿ ALARM WAS EMITTED, INDICATING THERE WERE NO INTERRUPTION OF THE THERAPY BY THE USER DESPITE THE SIGNIFICANT INCREASE IN INSULIN DOSE DELIVERY AND ACCELERATED EXPIRATION OF THE PODS. THE PDM HAS NOT BEEN RETURNED FOR INVESTIGATION. INSULET CONSIDERS THIS CASE TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    INSULET HAS REQUESTED FOR THE DEVICE TO BE RETURNED FOR INVESTIGATION, BUT THE HCP HAS DECLINED AND WILL RETAIN THE DEVICE UNTIL FURTHER NOTICE. INSULET IS ATTEMPTING TO OBTAIN THE PDM DOWNLOADED DATA IN ORDER TO COMPLETE AN ANALYSIS. UPON OBTAINING THIS DATA, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND COMA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. INSULET HAS BEEN IN CONTACT WITH THE PATIENT'S HEALTH CARE PROFESSIONAL AND PRESTATAIRE. FURTHER INFORMATION IS BEING SOLICITED AND AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT IN THE EVENING OF (B)(6) 2024, THE PATIENT WAS FEELING UNWELL AND DURING THE NIGHT OF (B)(6) 2024, THE PATIENT WAS FOUND UNCONSCIOUS BY HER HUSBAND AND WAS TAKEN TO THE EMERGENCY ROOM AND HOSPITALIZED IN (B)(6)). THE PATIENT¿S BLOOD GLUCOSE RESULTS WERE NOT COMMUNICATED TO INSULET. NO DEVICE MALFUNCTION WERE REPORTEDLY OBSERVED. ON (B)(6) 2024, THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) STATED TO INSULET THAT THE OMNIPOD DASH PDM SETTINGS INDICATE THAT THE PROGRAMMED BASAL SETTING WAS CHANGED FROM 1U/H TO 15U/H ON (B)(6) 2024 AT 16H00. IT IS UNKNOWN WHY THE SETTINGS WERE MODIFIED. THE HCP REPORTED TO INSULET ON THAT SAME DATE THAT THE PATIENT IS REMAINING UNCONSCIOUS AND IT IS UNLIKELY THAT SHE WILL RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336102 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000010 7752 10385082000139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization