MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	PT-000438
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been returned/received to date.We are unable to determine if insulet's device caused or contributed to the reported incident.No lot release records were reviewed, as the product lot number was not provided.The investigation is ongoing and insulet is attempting to recover additional details.If additional information is received, insulet will submit a supplemental report and conduct all possible investigation.Cloud - locked down/smartphone: data not available.Cloud - omnipod 5 software app version: data not available.Cloud - smartphone operating system: data not available.Cloud - smartphone hardware: data not available.Cloud - cgm sensor type: data not available.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.
Event or Problem Description
On (b)(6) 2025, a nurse called to inform insulet of a patient death.The patient was using omnipod 5 (op5) and libre 2+ sensor.The patient was found deceased at home by paramedics on (b)(6) 2025.The patient had started on op5 on (b)(6) 2025.The reason for death is currently unconfirmed but the nurse reports ¿the pump had not received a value from the sensor so they think it was hyperglycemia but the patient had ketoacidosis before'.If additional information is received a supplemental report will be submitted.Abbott has been notified of the event.
Additional Manufacturer Narrative
No lot details for the pod were reported.The pdm lot details were obtained from the cloud log review.Lot release records were reviewed and the product lot met all acceptance criteria.The physical device was not returned.Cloud data was downloaded and reviewed for the period of (b)(6) 2025.The last pod connected to the controller was activated at 18:49 on (b)(6) 2025.The patient history buffer (phb) data from the cloud showed that intermittent periods of pod-sensor signal loss occurred, indicated by an invalid estimated glucose value (egv) of -2, resulting in the controller generating several missing sensor values alerts.These instances of pod-sensor signal loss were between 5-45 minutes long, with the last invalid egv of -2 occurring at 05:14 on (b)(6) 2025.Pod-sensor signal loss accounted for 250 minutes of roughly 58 hours of cloud data available from this pod.The system entered automated mode at 19:59 on (b)(6) 2025.Review of the cloud data confirmed the automated algorithm was able to appropriately adjust the automated basal amounts based on the egvs received and user inputs.At 23:06 on (b)(6) 2025, the egvs reached 501, indicating the glucose reading received from the sensor was greater than 500 mg/dl.From 23:06 on (b)(6) 2025 until the last record was received from the pod at 10:04 on (b)(6) 2025, the egvs were either -2 or 501.The system remained in automated mode until and automated delivery restriction alert was generated at 03:59 on (b)(6) 2025 after the algorithm suggested the maximum amount of insulin for too long.The alert was acknowledged and the system entered manual mode at 04:00 on (b)(6) 2025 and remained in manual mode for the rest of the pod's use.While in manual mode, the system correctly delivered the user's programmed basal rate of 0.95 u/hr.It was confirmed that the total pulse count tracked by the pod increased at the user's basal programmed rate.The cloud data showed 8 boluses were delivered between (b)(6) 2025.The last bolus was 4.95 u and was delivered at 00:59 on (b)(6) 2025.It was confirmed that the total pulse count tracked by the pod increased by the bolus amount each time a bolus was delivered.No evidence of issues was observed in the available cloud data.

• Brand Name: OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22920723
• Report Number: 3004464228-2025-38742
• Device Sequence Number: 18046330
• Product Code: QFG
• UDI-Device Identifier: 10385083000138
• UDI-Public: (01)10385083000138
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000438
• Device Catalogue Number: POD-BLE-H1-529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 33 YR
• Patient Sex: Female