BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21621568 · Received March 17, 2025

    Report

    Report Number
    3004464228-2025-11514
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 17, 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

    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 AMBULANCE, LOSS OF CONSCIOUSNESS AND HYPOGLYCEMIA. 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. CLOUD - LOCKED DOWN/SMARTPHONE: LOCKDOWN. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION: 3.1.1. CLOUD - SMARTPHONE OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. CLOUD - SMARTPHONE HARDWARE: N5004L. CLOUD - CGM SENSOR TYPE: G6. 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.

    Description of Event or Problem · 0

    PATIENT REPORTED IN A PREVIOUS HOSPITALIZATION CAPTURED IN AN ASSOCIATED FILE, HER HEALTH CARE PROVIDER ADJUSTED HER PUMP SETTINGS PRIOR TO BE DISCHARGED. THE PATIENT REPORTED THE NEW SETTINGS WERE STILL TOO STRONG RESULTING IN HYPOGLYCEMIA AND A SECOND HOSPITALIZATION. BLOOD SUGAR DECREASED TO LESS THAN 70 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT'S HEALTH CARE PROVIDER CALLED TO CHECK ON HER, AND DID NOT GET AN ANSWER, THEREFORE THEY CONTACTED EMERGENCY SERVICES AND REQUESTED A WELLNESS CHECK. THE PATIENT REPORTED SHE HAD LOST CONSCIOUSNESS WHILE WATCHING TV DUE TO HYPOGLYCEMIA. EMERGENCY SERVICES ADMINISTERED IV GLUCOSE. THE PATIENT DECLINED GOING TO THE EMERGENCY ROOM. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17612 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U06152421 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female