BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 20104099 · Received August 29, 2024

    Report

    Report Number
    3004464228-2024-34582
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 3, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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

    IN THE CASE DESCRIPTION, THE USER MENTIONED THAT THE POD WOULD DELIVER INSULIN WHILE SUSPENDED. THE PHYSICAL CONTROLLER WAS NOT RECEIVED FOR INVESTIGATION. ANDROID LOG FILES FROM THE COMPLAINT DEVICE WERE UPLOADED TO THE CLOUD SYSTEM BY THE USER AND DOWNLOADED FOR INVESTIGATION. INSPECTION OF THE ANDROID LOG FILES FOUND NO EVIDENCE OF THE POD DELIVERING INSULIN WHILE INSULIN DELIVERY WAS SUSPENDED. THE AUDIT AND PHB AUDIT LOGS SHOW THAT THE COUNT OF PULSES DELIVERED DID NOT INCREASE WHILE INSULIN DELIVERY WAS SUSPENDED, INDICATING THAT THE POD WAS NOT DELIVERING INSULIN WHILE SUSPENDED. THE SYSTEM WAS DETERMINED TO FUNCTION AS INTENDED.

    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 HYPOGLYCEMIA. 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. INSULET PATIENT SAFETY REVIEWED THIS EVENT WHERE THE CUSTOMER REPORTED EXPERIENCING HYPOGLYCEMIA WHILE DESCENDING FROM A HIGH ALTITUDE AND THE DEVICE CONTINUES TO DELIVERY INSULIN WHEN PAUSED. THE OP5 USER GUIDE ADDRESSES ALTITUDE CHANGES AND POSSIBLE IMPACT TO THERAPY DELIVERY. IT IS RECOMMENDED THE CUSTOMER CHECK BLOOD SUGAR LEVELS FREQUENTLY, AND CONSULT WITH THEIR HCP FOR GUIDANCE/RECOMMENDATIONS. THE CUSTOMER DID NOT REQUIRE MEDICAL INTERVENTION, HYPOGLYCEMIA WAS TREATED WITH CARBOHYDRATE CONSUMPTION. IMPORTANT SAFETY INFORMATION PAGE 22: CAUTION: ALWAYS CHECK YOUR GLUCOSE FREQUENTLY DURING AMUSEMENT PARK RIDES AND FLYING OR OTHER SITUATIONS WHERE SUDDEN CHANGES OR EXTREMES OF AIR PRESSURE, ALTITUDE, OR GRAVITY MAY BE OCCURRING. RAPID CHANGES IN ALTITUDE AND GRAVITY, SUCH AS THOSE TYPICALLY FOUND ON AMUSEMENT PARK RIDES OR FLIGHT TAKE-OFF AND LANDING, CAN AFFECT INSULIN DELIVERY, LEADING TO POSSIBLE HYPOGLYCEMIA OR INJURY. IF NEEDED, FOLLOW YOUR HEALTHCARE PROVIDER'S TREATMENT INSTRUCTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO <70 MG/DL WHILE WEARING A POD. THE PATIENT REPORTED THAT THEY SUSPENDED THEIR POD INSULIN DELIVERY, BUT THE POD CONTINUED TO DELIVER INSULIN. AS TREATMENT, THE PATIENT ATE CARBOHYDRATES CONTAINING FOOD. PATIENT REPORTED THIS EVENT OCCURRED WHILE PERFORMING AN ACTIVITY WHERE HE WAS DESCENDING FROM A HIGH ALTITUDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356272 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000506

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male