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 03/14/2024

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 that the customer reported a linking issue with carelink personal and carelink pro.Troubleshooting was partially performed.The issue could not be resolved.No harm requiring medical intervention was reported.It was unknown whether the customer will continue using the device and will not be returned for analysis.

Manufacturer Narrative

Investigation/testing summary: an attempt was made to reproduce the issue by trying to link the test patient account in carelink system application to a test personal account and observed that the issue was not reproducible.However, to delve deeper into the matter, we scheduled a call with the helpline to troubleshoot the error.We identified the specific error from the logs and furnished the necessary information to the carelink development team for further investigation.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 due to the database indexing made on the patient audit table causing the error in new record creation analysis summary: the carelink development team investigated and determined that the issue stems from the database indexing in the patient audit table, resulting in the failure of the current database transaction in the functionality.The carelink database team created an internal tracking ticket to revert this indexing to resolve the issue.After the database fix was implemented, we requested the helpline to validate.The helpline confirmed that they were able to link the patient and personal records without encountering any issues.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.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: 18948114
• MDR Text Key: 338186508
• Report Number: 2032227-2024-145965
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/21/2024
• 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: 03/26/2024
• 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