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 Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 03/04/2020

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 low glucose (bg) level (value not provided), loss of consciousness, a seizure, and a patellar fracture.The cause of the low bg was unknown, however customer reportedly changed supplies and went to bed without checking bg levels.Low bg resulted in a seizure, and a loss of consciousness, which caused customer to sustain a patellar fracture.Subsequently, customer was hospitalized.Bg was treated with intravenous glucose, and surgery for patellar fracture.Reportedly, the customer was released on (b)(6) 2020 to a rehab center with the issue resolved.

• 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: 9934833
• MDR Text Key: 187730758
• Report Number: 3013756811-2020-33880
• 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: P180008
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 60