BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 15074848 · Received July 21, 2022

    Report

    Report Number
    3004464228-2022-12541
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 29, 2022
    Report Date
    June 30, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000006
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 INTERVENTION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE USER REPORTED EXPERIENCING HYPOGLYCEMIA WHILE USING THE SYSTEM. A BATTERY WAS NOT RETURNED WITH THE DEVICE. A KNOWN GOOD BATTERY WAS INSERTED INTO THE PDM, AND THE PDM POWERED ON WITH NO ISSUES. THE PDM SUCCESSFULLY PAIRED WITH AN UNUSED POD, DELIVERED A 5 UNIT BOLUS OVER A DISTANCE OF 5 FEET, AND DEACTIVATED THE POD. NO COMMUNICATION ISSUES WERE OBSERVED. INSPECTION OF THE LOG, AUDIT, AND IBF FILES SHOW THE DEVICE WAS FUNCTIONING AS INTENDED. ON THE DATE OF OCCURRENCE, THE DEVICE WAS OPERATING ON THE BASAL PROGRAM 'BASAL 1' AS SET BY THE USER, WHICH IS 5U/HR. A SINGLE 5 UNIT BOLUS DELIVERY WAS OBSERVED ON THE DATE OF OCCURRENCE THAT WAS SENT BY THE USER. THE SYSTEM WAS DELIVERING INSULIN BASED ON THE USER'S SETTINGS, WAS ABLE TO SUSPEND AND RESUME INSULIN DELIVERY AS COMMANDED BY THE USER, AND WAS ABLE TO SEND A BOLUS AS COMMANDED BY THE USER. NO SIGNS OF THE DEVICE OVER DELIVERING INSULIN WERE OBSERVED. CHANGED PRODUCT FROM - D4 - MODEL # 18320 T0 18341. FROM - D4 - CATALOG # BLE-I1-529 TO SKT-USA1-D001-MG-ENG FROM - D4 - UNIQUE IDENTIFIER (UDI) # (B)(4). FROM - G4 - PMA/510(K) # K192659 TO K211575 ADDED D4 SERIAL # 010401-03478 ADDED H4 - DEVICE MFG DATE- 10/13/2021

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT CALLED AN AMBULANCE FOR MEDICAL ASSISTANCE DUE TO HYPOGLYCEMIA. DESPITE GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL DETAILS, NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718909 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18341 20385082000006

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention