BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 APP

    MDR report key: 22512625 · Received July 15, 2025

    Report

    Report Number
    3004464228-2025-31421
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 16, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS. OMNIPOD SOFTWARE APP VERSION: 2.0.2. SMARTPHONE OPERATING SYSTEM: 18.5. SMARTPHONE HARDWARE: IPHONE17.2. CGM SENSOR TYPE: G7. 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.

    Additional Manufacturer Narrative · 0

    CHANGED D4 - PRIMARY UDI NUMBER. FROM (B)(4) TO (B)(4). CHANGED D4 - MODEL # FROM PT-002343 TO PT-000435. CHANGED D4 - CATALOG # FROM M009-2S-AP TO POD-BLE-H1-520.

    Description of Event or Problem · 0

    THE PATIENT SOUGHT MEDICAL ATTENTION ON (B)(6) 2025 AT THE HOSPITAL BECAUSE THEY WERE HAVING PERIODS OF TIME WHERE THEY WERE NOT RECEIVING READINGS IN THE OP5 APP, AND OTHER TIMES THE CGM (CONTINUOUS GLUCOSE MONITOR) READING WERE INCORRECT, WHICH LED TO HOSPITALIZATION. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS, BEING DISCHARGED ON SATURDAY, (B)(6) 2025. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT EXPERIENCED SEVERE SYMPTOMS, INCLUDING BEING UNABLE TO GET OUT OF BED, VOMITING EIGHT TIMES, AND NEEDING HELP FROM A FRIEND. THE DIAGNOSIS WAS DIABETIC KETOACIDOSIS (DKA), AND THE TREATMENT INVOLVED AN INSULIN DRIP IN THE INTENSIVE CARE UNIT, WHICH STABILIZED THE PATIENT'S BLOOD GLUCOSE LEVELS AFTER NINE HOURS. THE PATIENT REPORTED THAT THE HOSPITALIZATION WAS DUE TO THE SENSOR AND POD NOT COMMUNICATING PROPERLY. THE POD WAS WORN LESS THAN 1 HOUR ON INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138189 OMNIPOD 5 APP OMNIPOD 5 PODS QFG INSULET CORPORATION PT-000435 PH1U09102431 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization