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 11/29/2023

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 an error in the developer options.Troubleshooting was performed.The issue could not be resolved.No harm requiring medical intervention was reported.It was unknown whether the customer will continue using the device and will not be returned for analysis.

Manufacturer Narrative

An attempt to reproduce the reported event using minimed mobile app (software version 2.2.0) using various configurations was conducted and confirmed the issue was reproduced on following devices: sony xperia xz2 (android 10).Huwaei p30 (android 10).Samsung galaxy s9 (android 10).Xiaomi mi 9 se (android 11).Pixel 3 xl (android 11).Samsung galaxy s10 (android 12).Samsung galaxy a32 (android 13).The software did not successfully adhere to the specified requirements nor did it perform in accordance with the expectations.After conducting a thorough investigation, it was found that the issue is being caused by a security library incorrectly flagging the device for using a debugger tool.The mmm application shows the developer options screen in two scenarios: 1.When the developer options is turned on in the android settings or 2.When the zshield debugger detection tool detects that a debugger tool is being used on the device.In context of this issue, the zshield debugger detector reported that the device was running a debugger on the phone, when in reality there were none.To fix the issue the zshield version will be updated from 2.95.0 to 2.97.1.To assist with the resolution of the issue, we provided the helpline team with the following workaround to ensure that it is addressed effectively: 1.Open settings.2.Scroll down and tap 'about this phone'.3.Press 'build number' seven times.4.Enter your pin (set, if any) and done.5.Go to info phone and scroll down to developer options and disable.6.Return to the phone's home screen and press and hold minimed mobile app.7.Go to ""i"" (app info).8.Go to storage.9.Press clear data and clear cache.If above workaround does not work, the anticipated fix for this issue is scheduled to be included in the upcoming release of mmm 2.2.1.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: 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: 18389435
• MDR Text Key: 331298671
• Report Number: 2032227-2023-321068
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2023
• 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: 12/06/2023
• 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: 51 YR