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

Model Number 1002717

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

Patient Problems Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418)

Event Date 03/06/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that the customer's blood glucose (bg) was a bit low (value not provided); cause was not known.At the time of the event, the customer did not have a continuous glucose monitoring session on, as such the customer¿s parents were not aware that the customer¿s bg level was very low.Parent provided customer with dextrose.Bg elevated to 196 mg/dl.Parent delivered a correction bolus via pump (pump history showed 0.96 units of insulin delivered) and 30 minutes later customer experienced a seizure due to "very low bg".Parent provided dextrose and soda.Customer "woke up after 2 minutes".Bg was 84 mg/dl.Customer vomited and refused to eat.Ambulance transported customer to the hospital.Customer was treated with intravenous glucose and was discharged the same day.Upon follow up, family was "doing ok".No pump issues were identified.

• Brand Name: T:SLIM X2, BASAL-IQ, MMOL/L
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 11590356
• MDR Text Key: 242977743
• Report Number: 3013756811-2021-33221
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613021
• UDI-Public: (01)00850006613021
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1004223-D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/07/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INSULIN: NOVORAPID
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention