BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 17914529 · Received October 11, 2023

    Report

    Report Number
    3004464228-2023-28291
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 12, 2023
    Report Date
    September 21, 2023
    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

    THE DEVICE WAS RECEIVED DEPLOYED WITH THE ADHESIVE PAD ATTACHED TO THE BOTTOM HOUSING. NO DAMAGES OR DEFECTS WERE OBSERVED WITH THE ADHESIVE PAD OR THE ADHESIVE PAD'S WELDS. THE SOFT CANNULA MEASURED THE CORRECT FULL LENGTH ACCORDING TO SPECIFICATION AND DID NOT APPEAR DAMAGED. NO DAMAGES OR DEFECTS WERE OBSERVED IN THE FLUID PATH OR NEEDLE MECHANISM THAT WOULD INHIBIT THE SOFT CANNULA FROM PROPERLY INSERTING INTO THE INFUSION SITE. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD RESULT IN IRRITATION AT THE INFUSION SITE. ROOT CAUSES FOR THE REPORTED NOT PROPERLY INSERTED CANNULA, ADHESIVE FAILURE, AND IRRITATION AT THE INFUSION SITE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - CLINICAL CODE ADDED E171601, MEDICAL DEVICE PROBLEM CODE ADDED A040102 AND COMPONENT CODE ADDED G0405201.

    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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 328MG/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 THE POD'S ADHESIVE LIFTED UP AND THE SITE WAS RED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 328MG/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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067280 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K12112231 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female