BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 24798570 · Received April 7, 2026

    Report

    Report Number
    3014585508-2026-18583
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 15, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICAL DEVICE WAS NOT RETURNED FOR INVESTIGATION. IN THE CASE DESCRIPTION, THE USER MENTIONED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE VALUES AND DIABETIC KETOACIDOSIS DUE TO SLOW BOLUS DELIVERY. ADDITIONALLY, THE USER MENTIONED MISSING SENSOR VALUE MESSAGES BEING DISPLAYED DESPITE A SENSOR BEING CONNECTED. CLOUD DATA FROM THE USER FOR ON (B)(6) 2026 WAS DOWNLOADED AND REVIEWED. REVIEW OF THE PATIENT HISTORY BUFFER (PHB) DATA FOUND FREQUENT INVALID ESTIMATED GLUCOSE VALUES (EGVS) OF -1 AND -2, INDICATING THE SENSOR FAILED TO CONNECT AND THE SENSOR EXPERIENCED TEMPORARY ERRORS, RESPECTIVELY. URGENT HIGH GLUCOSE VALUES (GREATER THAN 500 MG/DL) WERE RECEIVED BY THE POD MULTIPLE TIMES ON (B)(6) 2026 AND ONCE ON (B)(6) 2026. THE PHB DATA SHOWS THAT THE SYSTEM OPERATED PRIMARILY IN AUTOMATED MODE, APPROPRIATELY ADJUSTING THE MICROBOLUS AMOUNTS BASED ON THE ESTIMATED GLUCOSE VALUES AND USER INPUTS. WHEN IN MANUAL MODE, THE SYSTEM CORRECTLY DELIVERED THE USER'S MANUAL BASAL PROGRAM REGARDLESS OF ESTIMATED GLUCOSE VALUES RECEIVED. REVIEW OF THE BOLUS RECORDS CAPTURED IN THE CLOUD DATA SHOWED THAT THE IMMEDIATE DURATION OF EACH BOLUS WAS THE EXPECTED NUMBER OF SECONDS BASED ON THE TOTAL BOLUS VOLUME AND THE PROGRAMMED BOLUS RATE OF 1 PULSE EVERY 2 SECONDS. THE TOTAL PULSES DELIVERED COUNT TRACKED BY THE POD CORRECTLY INCREMENTED BASED ON THE TOTAL BOLUS VOLUME, THE TIME THAT THE BOLUS WAS CONFIRMED, AND THE DURATION OF THE BOLUS DELIVERY. NO EVIDENCE OF A DELAY IN INSULIN DELIVERY WAS OBSERVED IN THE AVAILABLE CLOUD DATA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: LOCKDOWN: OMNIPOD SOFTWARE APP VERSION: 3.1.6, OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06, HARDWARE: N5004L, CGM SENSOR TYPE: L2+. 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.

    Additional Manufacturer Narrative · 0

    H3 CHANGED TO YES AS INVESTIGATION WAS COMPLETED.

    Description of Event or Problem · 0

    AT THE TIME THE EVENT WAS REPORTED TO INSULET ON 09-MAR-26, THE PATIENT REPORTED THEY HAVE BEEN IN HOSPITAL (B)(6) HOSPITAL) FOR A COUPLE DAYS DUE TO DIABETIC KETOACIDOSIS (DKA) (DKA WAS REPORTED UNDER INSULET REFERENCE NUMBER: (B)(4), FDA 3014585508-2026-14714, MHRA 2026/003/017/601/084). THE PATIENT REPORTED PERSISTENT HYPERGLYCAEMIA WITH BLOOD GLUCOSE LEVEL GREATER THAN 13.9 MMOL/L (250 MG/DL). THE PATIENT REPORTED THE HOSPITAL STAFF BELIEVED THAT THE OMNIPOD 5 CONTROLLER/PERSONAL DIABETES MANAGER (PDM) WAS FAULTY. THEY REPORTED THE BOLUS DELIVERY APPEARED UNUSUALLY SLOW, WHICH LED TO POST-PRANDIAL HYPERGLYCAEMIA DESPITE 7 UNITS OF INSULIN BEING ADMINISTERED 15 MINUTES BEFORE DINNER. INSULET RECEIVED ADDITIONAL INFORMATION ON 17-MAR-26 FROM AN MHRA USER REPORT 2026/003/016/501/015. THE PATIENT REPORTED BOLUS INSULIN DOSES WERE RECORDED AS DELIVERED, BUT THEIR BLOOD GLUCOSE LEVEL DID NOT RESPOND AS EXPECTED, WITH PERSISTENT HYPERGLYCAEMIA. THE PATIENT REPORTED THEIR BLOOD GLUCOSE LEVEL ONLY IMPROVED AFTER INSULIN WAS ADMINISTERED VIA INTRAVENOUS INFUSION AND INSULIN INJECTION PENS. THE PATIENT WAS REPORTED TO HAVE STOPPED USING THE OMNIPOD SYSTEM AND RETURNED TO INSULIN INJECTIONS USING INSULIN PENS. ABBOTT WAS INFORMED OF THIS EVENT ON 19-MAR-26. THIS IS PDM WAS USED WITH THE PODS REPORTED UNDER INSULET REFERENCE NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537332 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000592 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention