MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK PRO ONLINE; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Model Number MMT-7350

Device Problem Wireless Communication Problem (3283)

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

Event Date 03/12/2024

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.Select patient information cannot be provided due to regional privacy regulations.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 customer complained about report having issue connecting to care link personal.Troubleshooting was not performed, and the issue was escalated.No harm requiring medical intervention was reported.It was unknown whether the customer will continue the use of the application and the device will not be returned for analysis.

Manufacturer Narrative

Investigation/testing summary: an attempt to reproduce the issue was performed on a dell precision 7560 windows 11 enterprise  and carelink system 3.11.Issue was not reproduced.The software support team verified via csr that the carelink personal account had already been successfully linked to a carelink system account.To aid in resolving the issue, we shared the following workaround with the helpline team to ensure effective addressing: confirm whether the patient is already linked to the correct clinic.No information was provided regarding the nurse or clinic.The software successfully adhered to the specified requirements and performed in accordance with the expectations specified in the (b)(4).(most likely) root cause: due to user error, as account was already linked to carelink system account.New linking event was unnecessary.Analysis summary: we are proceeding to close this ticket as we have not received any response.If the reported issue is still ongoing, we kindly request you to open a new svn and create a new jira ticket, providing the updated information as requested.This will allow us to address the matter promptly and efficiently.Afc code: fb35af other device setting issue 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.

• Brand Name: CARELINK PRO ONLINE
• Type of Device: CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
• 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: 18927538
• MDR Text Key: 337956575
• Report Number: 2032227-2024-144359
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7350
• Device Catalogue Number: MMT-7350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2024
• 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: 33 YR