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

Model Number 1000354

Device Problems Crack (1135); Poor Quality Image (1408); Failure to Sense (1559)

Patient Problem Hyperglycemia (1905)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported that the pump touch screen was cracked, unresponsive, and unreadable.Customer¿s blood glucose (bg) level was 224-400 mg/dl.Customer attempted to address their bg level with a bolus via insulin pump but was transported to the emergency room (er) and subsequently admitted to the intensive care unit (icu) on (b)(6) 2022.Customer was treated with intravenous fluids of saline and insulin.Multiple attempts were made by tandem technical support to follow-up with the customer regarding discharge date, but no response was received.The customer reverted to an alternate method in 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: 14254109
• MDR Text Key: 290421023
• Report Number: 3013756811-2022-42798
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613731
• UDI-Public: 00850006613731
• 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: Other
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000354
• Device Catalogue Number: 1006379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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: NOVOLOG / NOVORAPID
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic