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

Model Number	PT-001788
Medical Device Problem Codes	Defective Alarm (1014); Incorrect Measurement (1383)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical controller was not received for investigation.Android log files from the complaint device were uploaded to the cloud system by the user and downloaded for investigation.Review of the android log files found no evidence of issues with the urgent low glucose alerts.The log files and supporting cloud data confirmed that the system generated urgent low glucose alerts when estimated glucose values (egvs) received by the pod from the sensor were at or below 55 mg/dl.The patient history buffer (phb) data showed that the automated algorithm was able to appropriately adapt the microbolus amounts based on the egvs from the sensor and the user inputs.Though the system correctly responded to the sensor values, it could not be conclusively determined from the available data if the sensor was correctly reading the user's blood glucose values.The exact cause of the reported discrepant blood glucose values could not be determined.Locked down smartphone: phone_control_android omnipod software app version: 3.1.1 operating system: ap3a.240905.015.A2.S921usqs4byf5 hardware: sm-s921u 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
The patient reported their continuous glucose monitor (cgm) indicated their glucose levels were between 160-180 mg/dl, while their actual blood glucose was 50 mg/dl.The omnipod 5 system did not pause insulin delivery due to inaccurate cgm readings.The patient also stated that they did not receive a low glucose alert from the omnipod 5 system until their glucose level dropped below 45 mg/dl.Cgm manufacturer notified of inaccurate glucose readings allegation.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22947632
• Report Number: 3004464228-2025-39239
• Device Sequence Number: 21116438
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: (01)10385083000565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 09/02/2025
• 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: 40 YR
• Patient Sex: Female