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 03/18/2024

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.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.Select patient information cannot be provided due to regional privacy regulations.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.

Event Description

Information received by medtronic indicated that the customer reported carelink uploader upload and software error issues.It was also reported that the customer could not be able use the carelink uploader due to error code 1c.Troubleshooting was performed.No harm requiring medical intervention was reported.It was unknown if the customer will continue or discontinue use of the device and the product will not be returned for failure analysis.

Manufacturer Narrative

"complaint summary: user reported difficulty with error code when attempting to launch.Investigation/testing summary: an attempt to reproduce the issue was not performed as it was not necessary to confirm issue.The software support team provided the helpline with the following troubleshooting and guidance: the error code "1c" suggests that carelink uploader was opened directly from the applications folder instead of through the carelink website.We recommend advising the user to utilize the "upload" button on the carelink website after logging into their account.Should they encounter any additional problems, please inform us.The software successfully adhered to the specified requirements and performed in accordance with the expectations specified in the (b)(4), version pch00113968.(most likely) root cause: due to carelink uploader not being launched properly through carelink website.Analysis summary: we are proceeding to close this ticket as we have not received any response.If the reported issue is still ongoing, we kindly request you to open a new svn and create a new jira ticket, providing the updated information as requested.This will allow us to address the matter promptly and efficiently.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: 19013506
• MDR Text Key: 339039704
• Report Number: 2032227-2024-149282
• Device Sequence Number: 1
• Product Code: PHV
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• 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: 03/27/2024
• 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: 123 YR