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

Model Number	PT-001827
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Dizziness (2194); Urinary Frequency / Polyuria (2275); Elevated ketones/Diabetic Ketoacidosis (2364); Ambulation or Postural Difficulties (2544); Polydipsia (2604)
Date of Event	02/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported experiencing severe hyperglycemia while away from home and without access to her controller, which she stated must remain plugged in continuously to function due to rapid battery drain.The event occurred while the patient was at work, where she did not have the controller available.She reported her blood glucose level reached approximately 532 mg/dl and experienced symptoms including weakness, dizziness, excessive thirst, frequent urination, and difficulty standing for prolonged periods.The patient left work and sought emergency medical attention on (b)(6) 2026.She was treated in the emergency department for approximately five hours and discharged the same day with a diagnosis of diabetic ketoacidosis.Treatment reportedly included intravenous fluids and an insulin drip.The patient stated she did not have the controller available at the time of the event, as it remained at her home plugged in to maintain power.No additional device messages or alerts could be reviewed for this event for this reason.
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to confirm or determine the root cause of the reported controller battery failure.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: data not available.Omnipod software app version: 3.1.1.Operating system: n5004l-am-q-mv01602-06-01.06.Hardware: n5004l.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.

• Brand Name: OMNIPOD 5 CONTROLLER
• 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 24742591
• Report Number: 3014585508-2026-16976
• Device Sequence Number: 8903898
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022
• 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): 03/31/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-001827
• Device Catalogue Number: PDM-H001-G-XX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown