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 Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/09/2022

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 the customer went to the emergency room (er) and subsequently admitted to the hospital¿s intense care unit with an low blood glucose (bg) level of 10 mg/dl.Reportedly, the customer delivered too large of a bolus and lost consciousness.Reportedly, customers husband had to call paramedics to be transported to the emergency room (er).During hospital stay, customer was treated intravenously with fluids of saline.Customer was released from hospital on (b)(6) 2022 with issue resolved and no permanent damage.Systems check with tandem technical support confirmed the pump is functioning as intended.

• 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: 14241333
• MDR Text Key: 290370225
• Report Number: 3013756811-2022-42035
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007301
• UDI-Public: (01)00853052007301
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1000096
• Device Catalogue Number: 1000898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic