BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21458368 · Received February 25, 2025

    Report

    Report Number
    3004464228-2025-07925
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 25, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Product Problem
    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. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE. *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 3.1.1 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 THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 515 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. THE PATIENT CONTACTED THEIR HEALTH CARE PROVIDER AND WAS ADVISED TO DRINK A LOT OF WATER. ADDITIONALLY, THE HEALTH CARE PROVIDER ASSISTED THE PATIENT WITH ADJUSTING SETTINGS FOR MANUALLY CALCULATING INSULIN WITH BLOOD GLUCOSE METER. THE PATIENT DID NOT GO TO THE HOSPITAL OR RECEIVE ANY OTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417385 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K05192431 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female