MAUDE Adverse Event Report: MEDTRONIC MINIMED CARELINK WEB UPLOADER; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Model Number ACC-7350

Device Problem Wireless Communication Problem (3283)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer was trying to upload details using carelink personal website, but it didn't upload with an error "server upload failed".Troubleshooting was performed but the issue was not resolved.The customer will continue to use the device.The device 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

"we conducted multiple attempts to reproduce the reported issue using various configurations: minimed mobile app (software version 2.1.0) on.Samsung galaxy s23 (android 13) with mmt-1880 770g pump (software version 5.2a), samsung galaxy s21 (android 12) with mmt-1880 770g pump (software version 5.2a), samsung galaxy s9 (android 10) with mmt-1885 780g pump (software version 6.5v), xiaomi 12 (android 12) with mmt-1880 770g pump (software version 5.2a), oneplus 10 pro (android 12) with mmt-1880 770g pump (software version 5.2a), motorola moto g9 plus (android 10) with mmt-1880 770g pump (software version 5.2a), huawei mate 20 pro (android 10) with mmt-1885 780g pump (software version 6.7v.3), google pixel 6 (android 13) with mmt-1884 780g pump (software version 6.21u), samsung galaxy s23 (android 13) with 780g pump (software version 6.7v), samsung galaxy s20+ (android 12) with 780g pump (software version 6.7v), the issue was not reproduced in these attempts.The software did not successfully adhere to the specified requirements and did not performed in accordance with the expectations specified in the document: (b)(4).After conducting a thorough investigation, we have found that the snapshot upload is failing due to a pump disconnection during the snapshot upload.The pump and phone app must be connected during the process of a snapshot upload since the app acts as a bridge between the pump information and carelink.Since the pump is disconnected during the process, the snapshot fails to upload to carelink.The first error we see in the pattern is a bluetooth gatt operation time out, meaning that the bluetooth session between the pump and app has not finalized within 30 seconds, thus closing the session.This then causes the app to manually disconnect the pump and try to reconnect.It was observed that the phone and app were able to reconnect every time after this error.The next error in the pattern, which is the root cause of the issue, was the get_repository_request_status failing due to a transfer_session_expired error.This error occurs in one of the steps in the snapshot upload process.This error is caused by the get_repository_request_status opcode exceeding its given timeout time of 35 seconds.This specific exchange during the manual snapshot fails, causing the entire snapshot upload to fail.Esf number: (b)(4).To assist with the resolution of the issue, we provided the helpline team with the following workaround to ensure that it is addressed effectively: ¿ make sure that the phone and pump are next to each other during the process.¿ remind the customer that the uploads could last for 2 hours.¿ if customer has recently updated the pump to 780g, delete the updater application from the phone.¿ delete and reinstall the minimed mobile application.¿ ensure both the phone and pump do not have any pairings.¿ make sure that there are no other apps which using a bluetooth connection on phone.¿ unpair and repairing pump and app.¿ set mmm app battery usage to unrestricted.¿ turn off power saving.¿ define mmm app as a never-sleep app.¿ switch adaptive battery to off.¿ reset network settings.¿ clear bluetooth cache.¿ if the previous steps have failed, please walk customer through uploading snapshots through a pc.¿ there have been reports that¿s uploading snapshots through the pc has resolved the issue on the mmm app.We have received feedback from the helpline regarding the results of the resolution steps.They have verified that these steps were effective in resolving certain issues while proving ineffective for others.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.

• 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: 18473613
• MDR Text Key: 332381412
• Report Number: 2032227-2024-104155
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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: 01/10/2024
• 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: 49 YR
• Patient Sex: Female