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

Model Number MMT-7350

Device Problem Computer Software Problem (1112)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the healthcare professional getting 'carelink uploader is either not installed or cannot reach the server, please contact admin' message.No harm requiring medical intervention was reported.Unable to resolve with existing troubleshooting or labeled instructions, issue escalated.No product return is required for mmt-7350.

Manufacturer Narrative

Select patient information cannot be provided due to regional privacy regulations.Investigation/testing summary: an attempt to reproduce the issue was not performed as issue is common and remediation steps are known.Investigation of logs does not show any upload failure.Most probable reason can be anti-virus software.Provided the following troubleshooting steps to helpline: - update the uploader to newer version 3.11.0 as it contains fixes for some common network issues.- - esf (b)(4).The software did not adhere to the specified requirements and not performed in accordance with the expectations specified in the 10542712doc_y, version pch00104012.(most likely) root cause: most likely due to security software interfering with uploader 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.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.

• 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: 18786433
• MDR Text Key: 337550943
• Report Number: 2032227-2024-132733
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• 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: 22 YR