MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL IQ, MG/DL; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1002717

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 03/20/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.

Event Description

It was reported that on (b)(6) 2021, the customer was nauseous.Blood glucose (bg)was elevated (>400 mg/dl) and ketones were present.Customer delivered a correction bolus and used an insulin pen, however, bg did not lower.On (b)(6), customer lost consciousness and was found on (b)(6).Customer was transported to the hospital and was admitted.Healthcare provider identified ketones as dangerous.Customer was treated with infusion and kalium.Bg normalized.Customer was discharged on (b)(6) 2021.Cause of elevated bg was not known.Prior to the event, on (b)(6), customer had changed the cartridge, infusion set and insulin.Customer reverted to using an alternate method of insulin therapy.

• Brand Name: T:SLIM X2, BASAL IQ, MG/DL
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• MDR Report Key: 11822576
• MDR Text Key: 250593674
• Report Number: 3013756811-2021-48786
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007998
• UDI-Public: (01)00853052007998
• Combination Product (y/n): N
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1002717
• Device Catalogue Number: 1004219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFUSION SET: AUTOSOFT90; INFUSION SET: AUTOSOFT90
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention