MAUDE Adverse Event Report: MEDTRONIC MINIMED UNKNOWN CARELINK; GLUCOSE OXIDASE, GLUCOSE

Model Number UNK_CARELINKSOFTWARE

Device Problem Computer Software Problem (1112)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer reported that was unable to generate reports and received an error while generating the report.Troubleshooting was not performed.No harm requiring medical intervention was reported.The customer continued the use of the application and it 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

Investigation/testing summary: an attempt was made to reproduce the issue by generating reports for the carelink personal user in the carelink support application and confirmed that the issue was reproducible.Identified that the user had time overlap between the meal periods within their ""preferences"" settings.To assist with the resolution , we informed the helpline with the below steps.-breakfast and overnight meal period duration is overlapping.Overnight end time is 07:00 am but breakfast from time has started 03:00 which is within the overnight period.So the time between each meal period should not be overlapping the software successfully adhered to the specified requirements and performed in accordance with the expectations specified in the software requirement and specification in ""sw requirement doc"" listed below.(most likely) root cause: the root cause of the issue was identified as overlapping meal period preferences, which resulted in the reported problem.Analysis summary: requested helpline support team to inform user to update the overlapping meal period range in account settings and try to generate reports.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.

• Brand Name: UNKNOWN CARELINK
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• 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: 18755855
• MDR Text Key: 335968569
• Report Number: 2032227-2024-130245
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK_CARELINKSOFTWARE
• Device Catalogue Number: UNK_CARELINKSOFTWARE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2024
• 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
• Patient Age: 67 YR