MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC NIMIMED GUARDIAN LINK (3) CGM; GUARDIAN LINK (3) CONTINUOUS GLUCOSE MONITOR

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2018

Event Type  malfunction  

Event Description

Summary: in (b)(6) of this year, i had problems with multiple failures of medtronic guardian link (3) continuous glucose monitor sensors.Failed sensors permitted pump to suspend delivery of insulin.Failed sensors caused pump to report and act on incorrect data.I reported failures to medtronic along with supporting data.Medtronic has not addressed the problems nor proposed a solution.Timeline and relevant info: my endocrinologist prescribed a medtronic 730g pump and medtronic guardian continuous glucose monitoring (cgm) system in (b)(6) 2018.I received the new pump and cgm in (b)(6) 2018.After training sessions with medtronic field staff, i began using the pump and cgm.I immediately had significant issues with both the pump and the cgm sensors.Of the seven sensors used the first week or so, 4 failed in the first 24 hours of use.They are designed to work 7 full days.I also had 8-10 alarms per day with the new pump, many of which were initiated by faulty sensor readings.The first few readings on the sensor were up to 100 points off from calibration meter; however, they did improve as time passed.I discontinued use of the cgm, but continued to use the 730 pump.I immediately reported the problems to medtronic, and i was asked to provide details of problems, serial number for the cgm transmitter, lot numbers for the failed sensors, and pump data during the time the problems were encountered.All of the requested info was provided to medtronic.I was told medtronic would investigate, determine the cause(s), and contact me with course of corrective action.After nearly 5 weeks, i had not heard back from medtronic, at which time i contacted medtronic.I was told nothing had been done to address the problems or my complaint.I was not provided with an explanation nor with their intent or plan to correct the issues.I was only given the choice to return the pump and cgm.I agreed to exchange the new 730 pump for an older model 530 pump.The cgm would be returned for refund to my insurance company, along with the difference in cost between 530 pump and the 730 pump.In (b)(6) 2018 dr (b)(6), (b)(6) prescribes medtronic 730 pump and cgm system.From (b)(6) 2018 to (b)(6) 2018: i worked with (b)(6) at medtronic to secure pump and cgm through my insurance company, (b)(6).Claim initially denied.Appeal denied.New request submitted after old 530 pump failed.Claim denied due to recent submission less than 6 months prior.My wife, (b)(6), contacted her employer's human resources dept for assistance.Payment then approved by (b)(6).On (b)(6) 2018, (b)(6) emailed that (b)(6) had approved payment.On (b)(6) 2018+/-, on our about (b)(6) 2018, a new medtronic 730g pump arrived, along with cgm system (transmitter, sensors, etc.).On (b)(6) 2018, training on new pump at (b)(6) with (b)(6), medtronic field rep.On (b)(6) 2018 training on cgm system at (b)(6) with (b)(6), medtronic field rep.On (b)(6) 2018 reported 2nd sensor failure to (b)(6) via text message.(b)(6) 2018 online training session for auto mode pump/cgm setting with (b)(6), medtronic field rep.(b)(6) 2018 texted (b)(6) to report 3rd sensor failure.On (b)(6) 2018 reported 4th sensor failure to (b)(6) via text message.I decided to abandon cgm for time being.I cancelled meeting for (b)(6) with ms (b)(6).During phone call same day, ms (b)(6) asked for relevant info to support her report to medtronic of issues.On (b)(6) 2018 sent info to ms (b)(6) regarding serial number of cgm transmitter, cgm box with numbers, cgm sensor lot numbers etc.On (b)(6) 2018 logged into carelink account, and uploaded data from pump and meter per ms (b)(6) request on (b)(6) 2018.On (b)(6) 2018 email to (b)(6) requesting update to complaint.No response to date.On (b)(6) 2018 to (b)(6) 2018 email discussions with (b)(6) at medtronic regarding return of pump, cgm, and replacement 530 pump.Type 1 diabetes mellitus.Medtronic return merchandise agreement (rma) #;s (b)(4).

• Brand Name: MEDTRONIC NIMIMED GUARDIAN LINK (3) CGM
• Type of Device: GUARDIAN LINK (3) CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): MEDTRONIC MINIMED; northridge CA
• MDR Report Key: 7956189
• MDR Text Key: 124002763
• Report Number: MW5080458
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2018
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 79