MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 PODS

Model Number	PT-002343
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Alteration in Body Temperature (4568)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sought medical attention for hypoglycaemia and loss of consciousness.The patient's blood glucose declined to 29 mg/dl.It was reported that the patient was unconscious, cold, unresponsive and was 'making noises with her eyes flipped back'.The patient was treated with intravenous glucose and was released the same day.It was reported that the patient had upgraded to a new iphone, the patient was using the omnipod app as the controller for her pods and their basal settings had been entered incorrectly.
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hypoglycemia.Locked down smartphone: phone_control_ios omnipod software app version: 2.1.0 operating system: 26.2 hardware: iphone18.2 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.
Additional Manufacturer Narrative
The physical device was not returned for investigation.In the case description, the user mentioned being hospitalized due to low estimated glucose values (egvs).Cloud data for the period of 06jan2026-11jan2026 was downloaded and reviewed.Review of the cloud data found that a controller with serial number (b)(6) was used up until 16:03 on 09jan2026.This controller was last used with a basal program of 20 pulses/hour (1 unit/hour) from 08:03 until 16:03 on 09jan2026.Prior to this time period, the user input basal rate changed between 0.25 units/hour, 0.3 units/hour, and 1 unit/hour.At 20:39 on 09jan2026, the controller serial number changed to (b)(6) and this controller was set up with a basal program of 60 pulses/hour (3 units/hour).On 10jan2026 at 18:51, the user input basal program was decreased to 16 pulses/hour (0.8 units/hour) while the controller with serial number (b)(6) was still in use.Review of the patient history buffer (phb) data found that leading up to and during the reported event, the system was in automated mode.While in automated mode, the system appropriately adjusted the microbolus amounts based on egvs and user inputs.The device appropriately suspended insulin delivery in automated mode when egvs were below 60 mg/dl.While the system was in manual mode, insulin delivery was manually suspended and the system correctly stopped delivery of basal insulin, as indicated by the total pulses delivered count tracked by the pod not increasing during the suspension period.No issues were observed with the system.It could not be conclusively determined if the initial basal program of 3 units per hour for the controller with serial number (b)(6) was intentionally and correctly setup based on the cloud data.The exact cause of the reported event could not be conclusively determined.

• Brand Name: OMNIPOD 5 PODS
• Common Device Name: OMNIPOD 5 PODS
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 24276708
• Report Number: 3014585508-2026-06142
• Device Sequence Number: 9962536
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: 10385083000459
• Combination Product (Y/N): N
• PMA/510(K) Number: K231826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown