MAUDE Adverse Event Report: MEDTRONIC MINIMED SFTWR MMT-6122 FOTA IOS OUS/US; MEDICAL DEVICE DATA SYSTEM

Model Number MMT-6122

Device Problems Computer Software Problem (1112); Appropriate Term/Code Not Available (3191)

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

Event Date 03/03/2024

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported that was unable to download the software for the 780g pump model and received a message containing that the software was unavailable and the pump was up to date.Troubleshooting was partially performed and found that the customer completed the training; however, the customer had not received a "ready for download¿ email.No harm requiring medical intervention was reported.The customer continued the use of the application and it will not be returned for analysis.

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, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Customer cannot update with fota app (app version 1.3.4).Analysis summary: after examining the device in teneo, it was discovered that the pump firmware remained in a 'pending' state.This situation arises when the pre-requisite message from sap experiences a delay or fails to transfer correctly to teneo.Consequently, customers receive an error message indicating that their pump is already up to date.To address this issue, an incident has been raised with the sap team in service now to manually re-trigger the eligibility message from sap to teneo if necessary.The sap team has found that the encounter is not fully released in idx since the patient program was not marked completed in periscope.This has been manually updated, and the customer should receive the "ready to update" email within 24 hours.Helpline stated that they will reach out to the customer to let them know that firmware will be ready to update once the customer receives the "ready to update" email.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.

• Brand Name: SFTWR MMT-6122 FOTA IOS 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: 18917206
• MDR Text Key: 337823087
• Report Number: 2032227-2024-143572
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-6122
• Device Catalogue Number: MMT-6122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 53 YR
• Patient Sex: Female