BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 22804963 · Received August 14, 2025

    Report

    Report Number
    3004464228-2025-36372
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    June 26, 2025
    Report Date
    September 8, 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
    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 HOSPITALIZATION AND HYPOGLYCEMIA. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS. OMNIPOD SOFTWARE APP VERSION: 2.0.2. OPERATING SYSTEM: 18.5. HARDWARE: IPHONE15.3. CGM SENSOR TYPE: G7.

    Additional Manufacturer Narrative · 0

    THE POD WAS FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD RESULT IN THE DEVICE OVER DELIVERING INSULIN. INSPECTION OF THE PATIENT HISTORY BUFFER (PHB) DATA SHOWED THAT THE AUTOMATIC GLUCOSE CONTROL (AGC) FUNCTIONED AS INTENDED AND WAS ABLE TO APPROPRIATELY ADAPT TO CHANGES IN ESTIMATED GLUCOSE VALUES (EGVS) AND USER INPUTS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4- MODEL # FROM PT-002343 TO PT-001662. CORRECTION TO D1 - BRAND NAME FROM OMNIPOD 5 APP TO OMNIPOD 5 PODS. CORRECTION TO D4 - CATALOG # FROM M009-2S-AP TO POD-OMNI-I1-6720.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS DECLINED TO 35 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED THEY DID NOT RECEIVE A LOW GLUCOSE ALERT. THE PATIENT WAS TREATED WITH DEXTROSE IN IV(INTRAVENOUS). THE PATIENT WAS RELEASED THE FOLLOWING DAY. THE POD WAS WORN WHEN SEEKING MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687195 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Hospitalization