MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. CONTROL IQ; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Patient Problems Pain (1994); Dysphasia (2195); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 10/13/2023

Event Type  Injury  

Event Description

The automatic correction bolus went off even though it was not supposed to.My sleep schedule is from 9pm to 8 am monday to sunday.While in control iq this automatic feature is supposed to be off.Quite honestly i was in the 50 it took my husband 45 minutes to wake me up due to the gabapentin, lorazepam, topiramate, montelukast.And if i had a cyclobenzaprine that night i was a hard wake up because my hips and shoulders both have bone spurs and the sciatica is also a nerve pain i don't wish on anyone.But being 50 and needing my husband's help to walk because i was shaking so much from the low and the fact i was having trouble communicating is a problem for me.It's a problem for everyone using the tandem and control iq.Because to turn off the automatic correction bolus i would need to turn off the control iq.My physician does not want that, dr (b)(6).1) to not give the user a choice in whether they want the autocorrect bolus to deliver is not good medical advice.2) to not give a choice but to turn off control iq the whole reason for purchasing the expensive piece of equipment is ridiculous and stupid.I might as well go back to shots.3) to not listen to a pumper who was here from the start of insulin pump in the us is ignorance and not taking the knowledge of an rf electrical engineer.Reference report: mw5147887.

• Brand Name: CONTROL IQ
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 18092276
• MDR Text Key: 327865582
• Report Number: MW5147888
• Device Sequence Number: 1
• Product Code: QJI
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White