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 03/05/2024

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, 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 accidentally changing the date to a future date, but after a couple of days, were able to correct it.Troubleshooting was performed and the issue could not be resolved.The customer tried to generate reports it does not have any data.No harm requiring medical intervention was reported.It was unknown whether the customer will continue the use of the application and the device will not be returned for analysis.

Manufacturer Narrative

Investigation/testing summary: an attempt was made to reproduce the issue by generating the daily review reports in carelink support application and observed that there is a future time change event made by the user which caused the data ambiguous for current date.As per the current system requirement, carelink reports cannot display data if a time change event has occurred.Consequently, the uploaded data becomes ambiguous for the current date due to such an event.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 future time change event performed on the pump causing the data ambiguous for current date.Analysis summary: provided helpline with the information on the time change event causing the data to be ambiguous for the report generation.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: 18901181
• MDR Text Key: 337629126
• Report Number: 2032227-2024-142367
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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