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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer received a message like oops, something went wrong screen.Troubleshooting was performed and found the customer able to access a web page and unable to access carelink personal.Advised to force close the minimed mobile application and relaunch it; however, the issue was not resolved.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.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

After examining the device in teneo, it was discovered that the pump firmware was successfully updated by the customer, however, the new firmware version was not updated to reflect the new software version and model number.This prevented the update message to successfully send from teneo to sap.To address this issue, an incident has been raised with the teneo team in service now to update the record, and manually re-trigger the update message from teneo to sap.As a result, the model number mmt-1884 has been updated in the sap portal as expected and no further investigation is required.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: 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: 18900294
• MDR Text Key: 337632438
• Report Number: 2032227-2024-141898
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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: ACC-7350
• Device Catalogue Number: ACC-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
• Patient Age: 72 YR
• Patient Sex: Female