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

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 01/01/2020

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 over 1200 mg/dl and a loss of consciousness.The cause of elevated bg was unknown.The customer went to the emergency room and was subsequently hospitalized in the intensive care unit.Bg was treated via an unspecified insulin treatment.Customer was unable to recall when they were released from the hospital, however, customer indicated the issue was resolved and no permanent damage was sustained.Customer believes pump and related supplies were 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: 12964828
• MDR Text Key: 281996980
• Report Number: 3013756811-2021-131018
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007295
• UDI-Public: 00853052007295
• 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: 12/08/2021

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 Model Number: 1000354
• Device Catalogue Number: 1000897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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