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 Hypoglycemia (1912)

Event Date 06/13/2023

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.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.

Event Description

Information received by medtronic indicated that the customer wanted to see the details of the low blood glucose and when the customer tried to generate the reports, the system was alarmed for conflicting data on (b)(6) 2023.The customer had tried all kinds of things but was unable to generate the reports.Troubleshooting was not performed.No harm requiring medical intervention was reported.It was unknown if the customer will continue the use of the software.The product will not be returned for analysis.

Manufacturer Narrative

Complaint summary: helpline support team reported that user was viewing conflict data error when they were trying to generate reports in carelink personal application.Investigation/testing summary: an attempt was made to reproduce the issue by generating reports within the carelink system using the provided username.It was verified that the issue could indeed be reproduced.Additionally, data retrieved from the carelink database was examined to determine if any time change events were recorded.Upon analysis, it was observed that the user had uploaded distinct data during two separate uploads conducted on june 12th.Consulting the carelink development team for deeper investigation, it was affirmed that the data within these two uploads differed significantly and couldn't be combined for report generation.This behavior aligns with the anticipated functioning of the system.To assist with the generation of reports, we provided the helpline team with the following steps to ensure that it is addressed effectively: can you please try excluding june 12th and generate reports? requested helpline if they need reports for entire june, if so we could try generating it manually.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 because of the different data uploads for a particular date, which made the data ambiguous.Analysis summary: carelink dev team confirmed that the data is ambiguous as there are different data on each upload.The helpline support team confirmed to close the ticket after providing the necessary evidence of deviation in data upload.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: justin ellis ; 18000 devonshire st.; northridge, CA 91325 ; 7635265677
• MDR Report Key: 17256700
• MDR Text Key: 318449383
• Report Number: 2032227-2023-230669
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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: 09/07/2023
• 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
• Patient Age: 36 YR