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

Model Number ACC-7350

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

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

Event Date 09/22/2022

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 the customer was getting an error message with the carelink pro and stated that the error message was regarding the security check of the carelink uploader application that failed.It was also stated that the customer was having issues with adding the exceptions to the av software.No harm requiring medical intervention was reported.The device will not be returned for analysis.

Manufacturer Narrative

Investigation/testing summary: based on error message, it was determined that some form of anti-virus or security software was interfering with uploader application.Met w/ customer on a call and used process monitor application to collect detailed logs about what customer's software was doing when trying to use uploader application.Was able to identify names of processes in logs that indicated that cisco security software was active while customer was using uploader.(most likely) root cause: cisco security software installed on customer's system was attempting to prevent the uploader launch.Analysis summary: determined source of software interference based on error message customer was receiving and collection of detailed diagnostic logs.Provided customer with information as well as guidance on how to add the necessary exclusions and exceptions to their cisco security software.Customer reported issue as resolved after applying recommended fixes.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: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 15751520
• MDR Text Key: 307071278
• Report Number: 2032227-2022-356977
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACC-7350
• Device Catalogue Number: ACC-7350
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR