MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. X2 TSLIM TANDEM PUMP WITH CONTROL IQ; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Device Problem Defective Device (2588)

Patient Problems Headache (1880); Overdose (1988)

Event Date 02/05/2020

Event Type  malfunction  

Event Description

Text below from the pt describing an adverse event with control iq.It seemed to overdose her on insulin and then failed.The algorithm and system didn't function properly.See tracing.Her words: "check out february 5th in the evening through february 6th morning.I changed my site around 9 pm.Went to bed around 10.Woke up around 11 with low alert.Drank juice.Woke up again around midnight sweating and anxious.Basically drank and ate over 120g of carb then went to bed.Blood sugars continued to run low all night.Then i got conclusions alerts starting right after breakfast.Usually when i clear the alert and do a small bolus it clears.This time it didn't.I change the site first.Still alerted.Then tried changing the tubing.Still alerted.Pulled 4 units out of the cartridge with a syringe and injected manually.Then had to go home from work (because i didn't bring any insulin to work and we don't keep extra there).Changed everything out.Was ketotic.Water and bolus.Went back to work because i had families to teach in the hosp.Took most of the day of giving corrections and water to get everything back in control.(b)(6), the tandem educator down in (b)(6) asked if i had been connected when i filled the tubing.Nope.I don't do that.Still, trying to figure out what the hell happened.After i ate the 120g i went to bed.The pump kept alarming but it figured the sensor wasn't working by that time.(i'd hit my "profanity" it mode).However, in the morning had a pretty wicked headache, and checked blood sugar and the sensor was working fine." fda safety report id# (b)(4).

• Brand Name: X2 TSLIM TANDEM PUMP WITH CONTROL IQ
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 9706693
• MDR Text Key: 179709309
• Report Number: MW5092988
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• 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: 45 YR
• Patient Weight: 59