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 Hyperglycemia (1905)

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

Customer reported difficulty detecting pump and/or blue adapter by carelink uploader."complaint summary: customer reported difficulty detecting pump and/or blue adapter by carelink uploader.Investigation/testing summary: carelink support team investigated uploader database application logs to find the name and type of error causing the customer's issue.After conducting a thorough investigation, we have found that the uploader development team would need to be involved as error was occurring for many customers and was only occurring in specific regions on specific versions of microsoft windows.The uploader development team reported that they successfully replicated the problem and identified it as being caused by a bug within the uploader driver language logic handling.The software did not successfully adhere to the specified requirements and performed in accordance with the expectations specified in the 10542712doc_x, version pch00098029, requirement usr-230 & usr-642.(most likely) root cause: based on the investigation by the development team they found a language detection bug in the uploader language logic handling.Analysis summary: the uploader development team created and tested a fix for the issue.It is slated for release with uploader 3.10.0.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 reported the ble-stick was not recognized.Troubleshooting was performed for general documentation but the issue was not resolved.No harm requiring medical intervention was reported.It was unknown whether the customer will continue the use of the device.The samd technical assessment was performed.

• 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: 18354021
• MDR Text Key: 331198570
• Report Number: 2032227-2023-318430
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 08/03/2023
• 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: 11 YR