BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21719740 · Received March 28, 2025

    Report

    Report Number
    3004464228-2025-13507
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    March 16, 2025
    Report Date
    March 28, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 TREATMENT AND HYPERGLYCEMIA. 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. *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT. CLOUD - LOCKED DOWN/SMARTPHONE LOCKDOWN CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.0.1 CLOUD - SMARTPHONE OPERATING SYSTEM N5004L-AM-Q-MV01602-06-01.06 CLOUD - SMARTPHONE HARDWARE N5004L CLOUD - CGM SENSOR TYPE G6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD REQUIRED INTERVENTION FOR HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 471 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTS HAVING NAUSEA. THE PATIENT REPORTS THEY HAD NOT ADMINISTERED A CORRECTION BOLUS AND THEY HAD NOT BEE WEARING A CONTINUES GLUCOSE MONITOR. THE PATIENT WAS TAKEN TO URGENT CARE. ONCE AT URGENT CARE THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN. IN ADDITION THE PATIENT REPORTS BEING TREATED FOR AN ABSCESS WHILE AT URGENT CARE THE SAME DAY WHICH HAS BEEN REPORTED AN A SEPARATE CASE. THE PATIENT WAS AT URGENT CARE FOR 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580536 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U08132411 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male