MAUDE Adverse Event Report: MEDTRONIC MINIMED SOFTWARE, PRAAS VERSION 2.0A; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Model Number ACC-7333

Device Problem Computer Software Problem (1112)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported issue to download data from august 2021 until november 2021.Customer received error when attempting to generate carelink report, carelink report was not displayed as expected, or possible issue with data in carelink report.Troubleshooting was performed but the issue could not be resolved.The issue was escalated.No harm requiring medical intervention was reported.It was unknown if the customer will continue the use of the device or not.The product 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.Select patient information cannot be provided due to regional privacy regulations.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

(b)(4).Fa21af software anomaly (defect) helpline support team reported the user is seeing error while trying to generate the reports from carelink personal application "complaint summary: helpline support team reported the user is seeing error while trying to generate the reports from carelink personal application investigation/testing summary: an attempt was made to reproduce the issue by trying to generate the reports in carelink support application and confirmed that the issue was reproducible.After conducting thorough investigation we observed that the user has enabled control code for longer duration which caused failure in report generation.We do not have a work around for this issue.The software successfully adhered to the specified requirements and performed in accordance with the expectations specified in the software requirement and specification document listed below under ""sw requirement doc.(most likely) root cause: the root cause of this issue is that the user had enabled control code during 2021 which caused the upload to be larger in size analysis summary: to avoid such issues in future , there was an enhancement created which provided the limitations in setting the control code.User's wont be having any issues in generating reports post the enhancement.Esf number(b)(4).Afc code: fa21af software anomaly (defect) 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: SOFTWARE, PRAAS VERSION 2.0A
• 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: 18281257
• MDR Text Key: 329901177
• Report Number: 2032227-2023-313340
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACC-7333
• Device Catalogue Number: ACC-7333
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2023
• 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: 31 YR