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

Model Number ACC-7350

Device Problem Computer Software Problem (1112)

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

Event Date 09/26/2023

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, 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.

Event Description

Information received by medtronic indicated that customer was unable to reinstall uploader.Troubleshooting was partially perfromed.No harm requring medical intervention was reported.It was unknown whether the customer will continue the use of the device and the device will not be returned for analysis.

Manufacturer Narrative

Hcp reported having inquiries related to carelink uploader and also about error 18 "complaint summary: hcp reported having inquiries related to carelink uploader and also about error 18 investigation/testing summary: met with clinic it staff to discuss the requirements they had to meet in order to use carelink uploader.They also had inquiries about security and policy specifics related to carelink as a platform.Shared these inquiries with the relevant teams and provided the following response to clinic it staff.When will sso be available for carelink system? currently we do not offer integration with active directory.However, the clinic admin can manager their users through the applications.Windows server 2012 end of life upgrade path or plan.We plan to move off of windows 2012 by the end of the year.Currently only our report servers use windows.Soc2 certification medtronic maintains a soc2 type 2 report reflecting the infrastructure security of the hosting environment for diabetes carelink system.This can be provided upon request.Use of web beacons the privacy policy was updated on dec 16, 2019 the privacy policy is a us medtronic diabetes privacy policy.Currently carelink systems does not use web beacons at all anywhere in our software.The software successfully adhered to the specified requirements and performed in accordance with the expectations specified in the 10541263doc_w, version pch00098027.(most likely) root cause: carelink uploader not actively supporting active directory single sign on.Analysis summary: provided approved answers to all inquiries shared by clinic it staff.All further communications done through attached email thread.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 WEB UPLOADER
• 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: 18000631
• MDR Text Key: 326464233
• Report Number: 2032227-2023-289512
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/1900
• Device Model Number: ACC-7350
• Device Catalogue Number: ACC-7350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2023
• 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