MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 ANDROID APP; OMNIPOD 5 APP

Model Number	PT-000559
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Loss of consciousness (2418); Cognitive Changes (2551)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physical device was not received for investigation.Cloud data from the user for the day of 21jan2026 was downloaded and reviewed.Review of the patient history buffer (phb) data showed that the pod was receiving updated estimated glucose values regularly from the sensor and adjusting insulin delivery based on those values.No instances of extended periods of 134 mg/dl were observed in the phb data.The phb data showed that the automated algorithm was able to appropriately adjust the microbolus amounts based on the estimated glucose values and user inputs.It could not be conclusively determined if the paired sensor was correctly reading the user's glucose levels or if the sensor was correctly transmitting the information to the pod, though it could be determined that the system responded correctly to the sensor values received.It also could not be determined if the dexcom and omnipod 5 apps were displaying the sensor values correctly from the available data.The exact cause of the reported event could not be determined.Cloud - locked down/smartphone lockdown.Cloud - omnipod 5 software app version 3.1.6.Cloud - operating system n5004l-am-q-mv01602-06-01.06.Cloud - hardware n5004l.Cloud - 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.
Event or Problem Description
It was reported that the omnipod app and dexcom continuous glucose monitor were displaying conflicting blood glucose results.The patient stated he began feeling tired, confused, and became unconscious.He woke up 2-3 hours later and looked at his omnipod app and it displayed a blood glucose of 134 mg/dl while his dexcom app showed a blood glucose of 355 mg/dl.He restarted his android phone and then the omnipod app still read the blood glucose as 134 mg/dl.He did a fingerstick blood glucose, which was around 300 mg/dl.He manually entered this fingerstick blood glucose reading into the omnipod app to receive insulin.The patient was feeling ok at the time of the report.

• Brand Name: OMNIPOD 5 ANDROID APP
• Common Device Name: OMNIPOD 5 APP
• 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: 24591387
• Report Number: 3014585508-2026-13683
• Device Sequence Number: 13121740
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: (01)10385083000565
• Combination Product (Y/N): N
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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-000559
• Device Catalogue Number: M009-P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/13/2026
• 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: 49 YR
• Patient Sex: Male