BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 24468994 · Received February 27, 2026

    Report

    Report Number
    3014585508-2026-10638
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 27, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT ASSOCIATED WITH MEDWATCH MW5183508 RECEIVED 04-MAR-2026. A4, A6, B1, B5, E4, G3, H2 AND H10 HAVE BEEN UPDATED ACCORDINGLY. THE PHYSICAL DEVICE WAS NOT RECEIVED FOR INVESTIGATION. CLOUD DATA FOR THE PERIOD OF (B)(6) 2025-(B)(6) 2025 WAS DOWNLOADED FOR REVIEW. INSPECTION OF THE PATIENT HISTORY BUFFER (PHB) FILE INDICATES THAT THE POD SERIAL NUMBER LISTED ON THE COMPLAINT PAGE (B)(6) WAS ACTIVATED AT 04:20 ON (B)(6) 2026 IN THE USER'S TIME ZONE. A 0.85U BOLUS WAS FOUND TO BE DELIVERED DIRECTLY AFTER ACTIVATION ALSO AT 04:20 ON (B)(6) 2026. THE SYSTEM IMMEDIATELY BEGAN OPERATING IN AUTOMATED MODE: LIMITED FOR THE FIRST 20 MINUTES OF POD ACTIVATION AS EXPECTED. WHILE IN AUTOMATED MODE: LIMITED, THE SYSTEM WAS DELIVERING AT THE LOWER OF THE USER'S MANUAL MODE AND ADAPTIVE BASAL RATE, AS EXPECTED. THE SYSTEM THEN SWITCHED TO AUTOMATED MODE, BUT THE USER WAS RECEIVING INTERMITTENT PERIODS OF -1 EGV INDICATING A FAILURE TO CONNECT BETWEEN THE POD AND CONTINUOUS GLUCOSE MONITOR. WHILE IN AUTOMATED MODE, THE SYSTEM WAS CORRECTLY ADJUSTING SUGGESTED INSULIN BASED ON EGVS AND WAS FOUND TO BE DELIVERING AT THE MAX RATE SEVERAL TIMES DURING THE RUN IN RESPONSE TO HIGH EGVS RECEIVED. AT 05:56 ON (B)(6) 2026, ANOTHER BOLUS WAS DELIVERED AND WAS OF 4.6U. THE PULSES DELIVERED BY THE POD MATCHES UP WITH THE TOTAL VOLUME OF EACH BOLUS, INDICATING BOTH BOLUSES WERE FULLY DELIVERED. EGVS WERE FOUND TO INCREASE TO 380 MG/DL BY 04:45 ON (B)(6) 2026 BEFORE DECREASING TO 290 MG/DL BY 07:15 ON (B)(6) 2026. AT 07:31 ON (B)(6) 2026 THE POD WAS FOUND TO GENERATE AN ALARM WITH ERROR CODE ENDING 19-02403-01351-064. THIS INDICATES THAT THE POD GENERATED AN 0X40 HAZARD ALARM INDICATING ROTATIONAL SENSOR MAXIMUM OPEN COUNT EXCEEDED. THE EXACT CAUSE OF THIS ALARM COULD NOT BE DETERMINED FROM THE CLOUD DATA. THE POD WAS DEACTIVATED AT 07:41 ON (B)(6) 2026. NO ISSUES WERE FOUND WITH INSULIN DELIVERY BASED ON THE AVAILABLE CLOUD DATA. HOWEVER, WITHOUT THE RETURNED POD, IT COULD NOT BE DETERMINED IF THE CANNULA WAS BENT OR THERE WERE ANY ISSUES WITH THE POD THAT WOULD HAVE PREVENTED INSULIN DELIVERY.

    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 HOSPITALIZATION AND 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. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS, OMNIPOD SOFTWARE APP VERSION: 2.1.0, OPERATING SYSTEM: 26.0, HARDWARE: IPHONE15.2, CGM SENSOR TYPE: G7. 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.

    Description of Event or Problem · 0

    FOLLOW UP WAS RECEIVED VIA MEDWATCH ON 04-MAR-2026. IT WAS CLARIFIED THAT FOUR PODS HAD BEEN ASSOCIATED WITH THE HYPERGLYCEMIA. TWO PODS FAILED THE EVENING ON VERBATIM "(B)(6) 2026." THE PATIENT'S BLOOD GLUCOSE INCREASED TO 420 MG/DL AND LARGE KETONES IN THEIR URINE. THEY WERE SEEN IN THE EMERGENCY ROOM (ER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION AT THE HOSPITAL WITH HYPERGLYCAEMIA ON (B)(6) 2026. THE PATIENT¿S BLOOD GLUCOSE LEVELS ROSE ABOVE 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SEVERAL CORRECTION BOLUSES OF INSULIN WERE PROGRAMMED; HOWEVER, THESE DID NOT BRING THE PATIENT¿S BLOOD GLUCOSE DOWN AND THEY STARTED VOMITING. IT WAS ALSO REPORTED THAT THE PATIENT HAD A HIGH KETONE LEVEL (NO EXACT VALUES PROVIDED). THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE THEY WERE TREATED WITH FLUIDS AND ELECTROLYTES. THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE ALSO MONITORED. WHEN THE POD WAS REMOVED AT THE HOSPITAL, THE CANNULA WAS FOUND TO BE BENT. THE PATIENT WAS RELEASED 5 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534279 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U08162531 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Required Intervention