MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 PODS

Model Number	PT-001662
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905); Vomiting (2144); Malaise (2359)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sought medical attention at the emergency room on (b)(6) 2026 with hyperglycaemia and dehydration.The patient¿s blood glucose rose to 450 mg/dl while wearing the pod between 4 and 24 hours.It was reported that the patient recalls receiving an automated delivery restriction alert.When the patient woke up, their blood glucose levels measured 450 mg/dl, the patient administered several correction boluses of insulin, but this did not bring the blood glucose levels within range.The patient reported symptoms of vomiting and malaise.The patient was treated with intravenous electrolytes and manual insulin injections.The patient was released the next day on (b)(6) 2026.
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 hospitalization and hyperglycemia.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: 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.High blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.[1] beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019; 13:614-626 [2] welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019; 10:751-755 [3] puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019; 21:155-158.

• 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: 24743162
• Report Number: 3014585508-2026-16993
• Device Sequence Number: 8731566
• Product Code: QFG
• UDI-Device Identifier: 20385083000579
• UDI-Public: (01)20385083000579(11)250625(17)270625(10)PH1U06252541
• 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
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-001662
• Device Catalogue Number: POD-OMNI-I1-6720
• Device Lot Number: PH1U06252541
• 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
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female