BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 16736277 · Received April 13, 2023

    Report

    Report Number
    3004464228-2023-09664
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 24, 2023
    Report Date
    May 16, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Product Problem
    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. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025 AND INFORMATION HAS BEEN UPDATED. UPDATED B5: FROM "IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ABDOMEN). IT WAS ALSO REPORTED THAT T\HE SITE WAS RED AND HAD SWELLING." TO "IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED THAT THE CANNULA DID NOT DEPLOY INDICATING A NEEDLE MECHANISM FAILURE. IT WAS ALSO REPORTED THAT THE SITE WAS RED AND HAD SWELLING." UPDATED H6 MEDICAL DEVICE PROBLEM CODE: FROM A150206 TO A050501.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ABDOMEN). IT WAS ALSO REPORTED THAT T\HE SITE WAS RED AND HAD SWELLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED THAT THE CANNULA DID NOT DEPLOY INDICATING A NEEDLE MECHANISM FAILURE. IT WAS ALSO REPORTED THAT THE SITE WAS RED AND HAD SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250758 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K03262211 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female