MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000096

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

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

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the customer experienced a blood glucose (bg) level of 23 mg/dl, respiratory distress, and a loss of consciousness. The cause of the low bg was unknown. Subsequently, customer was transported via ambulance to the hospital, and subsequently hospitalized in the intensive care unit. Customer was administered glucagon while being transported via ambulance, and once customer was hospitalized, treatment was administered via intravenous insulin, antibiotics, and customer was put on a breathing and feeding tube. Reportedly, the customer was released on (b)(6) 2021. Pump data review by tandem technical support confirmed the pump was functioning as intended. Customer reverted to manual injections for insulin therapy.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
• 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: 11475720
• MDR Text Key: 239502430
• Report Number: 3013756811-2021-28281
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1000096
• Device Catalogue Number: 1000898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 03/12/2021 Patient Sequence Number: 1

Treatment

INSULIN TYPE: NOVOLOG / NOVORAPIDINFUSION SET PRO