MAUDE Adverse Event Report: MEDTRONIC MINIMED SMARTPHONE IOS APP: PUMP CONNECT; INSULIN PUMP SECONDARY DISPLAY

Model Number	MMT-6102
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Select patient information cannot be provided due to regional privacy regulations.We have attempted to reproduce the pairing failure with a supervisor timeout on the mobile device, xiaomi 12 with 780g pump running firmware version 6.7 and 6.23.The issue occurred consistently on this device resulting in pairing failure.The xiaomi 12 was initially pairing successfully on android 13 and was recently updated to android 14 for testing.The issue is 100 percent reproduced on xiaomi 12 with android 14.After conducting an initial investigation, we have found that the main reason for failed connection attempts was supervisor_timeout errors thrown by os, supervisor_timeout in substance means that the phone did not receive any messages from the pump in the defined period (approximately 30 seconds), the main possible causes for that are errors in device bluetooth stack implementation or high level of electromagnetic noise, leading to automatic disconnection with pump or an error message.This issue has been reported multiple times, affecting operational efficiency and causing disconnection in the pairing process.After through investigation on supervisor_timeout errors, we found that during the pairing process, the mobile device sent incorrect data in response to a request for specific bluetooth information (known as gatt characteristics) resulting in supervisor_timeout.The software did not adhered to the specified requirements and failed to performed in accordance with the expectations specified in the software requirement and specification document: (b)(4).The esf number that corresponds to the reported issue is: (b)(4).This issue is about the pump being unable to pair with the minimed mobile app because the mobile device sent an incorrect response when trying to connect.We kindly ask that you try using a different phone, only if one is available¿either android or ios, with a preference for ios if possible until we find a solution.We apologize for any inconvenience this may cause and greatly appreciate your patience and understanding as we work to resolve this issue.In addition, the development team is actively working on finding a permanent fix for this pairing issue, and further updates will be provided as we progress.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported to medtronic minimed that the customer experienced no communication between the pump and the mobile app.The customer reported no adverse event.The event involved product(s) mmt-6102.Troubleshooting was performed and the customer was advised to re-launch minimed mobile app and follow the pairing process to pair the pump and mobile device but the pairing failed and hence the issue was escalated.No harm requiring medical intervention was reported.No product return is required for mmt-6102.

• Brand Name: SMARTPHONE IOS APP: PUMP CONNECT
• Common Device Name: INSULIN PUMP SECONDARY DISPLAY
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: lusine boyadzhyan ; 18000 devonshire st.; northridge, CA 91325
• MDR Report Key: 21534891
• Report Number: 2032227-2025-132108
• Device Sequence Number: 14660314
• Product Code: PKU
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: MMT-6102
• Device Catalogue Number: MMT-6102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown