MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Model Number 001002717

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

The summary is that my insulin pump threw a crc error 13 days prior losing data, and today has temporarily 'lost' basal data.On (b)(6) 2021 at 00:44 pst my pump lost all historical logs; specifically it threw crc alerts and lost part, then all of it's historical log.All that remains is a 'data log corrupted 39' log entry.Profile data- based on my manual checking of it at that time- looked unaffected.Tech support was called, they considered the problem 'normal' and told me to keep using it as is.As of today, (b)(6) 2021, i went into 'total daily dose' at ~19:30 pst; while it displayed the days total insulin correctly, it was claiming 100% of my dosing was from bolus.Accessing (b)(6), it shows the same, 100% bolus, 0% basal.(b)(6) showed the same.At this point i back out of the 'total daily dose' history reports, and access my basal history logs; this is empty, literally no days, no data.Profile data and current basal rate is reported as correct, but the basal history is entirely gone and there are no alerts or errors in this regard.No alert was raised, nor is there any error logged (either in the 'alert and errors', or 'complete logs' views).Being that the pump had a crc error that wiped all journal/logs on (b)(6), i assume the pump is again failing; i take care of other night meds, and prepare to call tandem- approximately 20:00 pst.I repeat the 'repro' steps from above, and find that the basal data is now correctly attributed in 'total daily dose', that the basal logs now show multiple days of data, etc.I call tandem at 20:06 pst to report the issue, and connect w/ support.I explain the issue (verbatim detailing the 'repro'), including that the behavior has me concerned as to the safety of using the pump since it's misbehaving.They ask for 30 minutes to review the logs; i do a fresh upload of all logs via their t:connect software.They call back at 20:52 pst, report that they've gone through the logs, and see nothing on there end.No further diagnostic actions suggested, no further steps suggested, effectively the agent isn't saying anything further.I make clear that 2 separate misbehaviors in under 2 weeks means it needs replacing or repair; so far the profile data hasn't been touched, but if that occurs, injury will follow.She has to escalate to her manager, thus will call back; 21:21 pst: i receive a callback.Again, agent seems unwilling to discuss/acknowledge next steps, so i again ask for it to be replaced/swapped; i offer to leave it powered on (whatever they need) so they can debug it.Their 'next steps' are an email was sent to 'field team' asking for approval, and that the agent will proactively try to track it.I'll have an answer when i get one; the agent's guess is 2 business days.There is no direction given to me to discontinue the pump, nor other things to watch for, nor acknowledgement of the error report.I point out that they have no explanation for the crc failure 13 days prior, and it's acting up in a different way; lack of logs doesn't mean the device is performing correctly.I'm very clear i have concern for what may happen if the next time the issue isn't in the logs, but is instead in my profile data (which is a concern that they raised both during the crc issue, and during this report- "is your profile data correct?").The case id for the (b)(6) 2021 series of calls is f2c6f6; the agent was cathy.Fda safety report id# (b)(6).

• Brand Name: T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 12615982
• MDR Text Key: 276350565
• Report Number: MW5104536
• Device Sequence Number: 1
• Product Code: QJS
• 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: 10/07/2021

1 Device was Involved in the Event

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
• Device Model Number: 001002717
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR