MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number	PT-000435
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had been hospitalized with hypoglycemia.The patient's blood glucose levels declined to 28 mg/dl while wearing the pod between 24 and 36 hours.The patient reports feeling dizzy and loosing consciousness.The patient reports receiving incorrect readings from their dexcom sensor that showed blood glucose levels at 185 mg/dl but when checking by finger stick their blood glucose level was below 70 mg/dl.Once the paramedics had arrived the patient was treated with sugar injections and their blood glucose level was below 30 mg/dl.The patient was taken to the hospital.Treatment at the hospital was not provided.The patient was at the hospital for 5 hours.
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 hypoglycemia.No lot release records were reviewed, as the product lot number was not provided.*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.Cloud - locked down/smartphone lockdown.Cloud - omnipod 5 software app version 3.1.1.Cloud - operating system.N5004l-am-q-mv01602-06-01.06.Cloud - hardware n5004l.Cloud - cgm sensor type g7.

• Brand Name: OMNIPOD INSULIN PUMP
• Common Device Name: PUMP, INFUSION, INSULIN
• 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: 22529967
• Report Number: 3004464228-2025-31767
• Device Sequence Number: 15325325
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000435
• Device Catalogue Number: POD-BLE-H1-520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Unknown