MAUDE Adverse Event Report: MEDTRONIC MINIMED SFTWR MMT-6121 FOTA ANDROID OUS/US; MEDICAL DEVICE DATA SYSTEM

Model Number MMT-6121

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information received by medtronic indicated that the customer reported communicating to our servers when updater app was checking for pump update.Troubleshooting was performed and the issue was not resolved.No harm requiring medical intervention was reported.The customer will discontinue using the insulin pump and insulin pump will be returned for analysis.

• Brand Name: SFTWR MMT-6121 FOTA ANDROID OUS/US
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• 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: 18995052
• MDR Text Key: 339005109
• Report Number: 2032227-2024-147770
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-6121
• Device Catalogue Number: MMT-6121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female