MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 1000096

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

Patient Problems Hyperglycemia (1905); Sepsis (2067); Diabetic Ketoacidosis (2364)

Event Date 04/02/2019

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 diabetic ketoacidosis (dka), and an elevated blood glucose (bg) levels (value not provided) and low blood glucose levels of 60 mg/dl, sepsis, and the flu.Reportedly, the cause was sepsis.The customer attempted to resolve the issue by visiting healthcare provider.The customer went to the emergency room (er) where an insulin drip, and additional unknown medicine was administered to try to resolve the issue.Subsequently, the customer was admitted to the hospital where insulin drip, and prophyol were administered to resolve the issue.Additionally, the customer was incubated.The customer confirmed that the pump and related supplies were functioning as intended.Reportedly, the customer was released from the hospital on (b)(6) 2019 with the issue resolved and no permanent damage.

• Brand Name: T:SLIM G5 SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: 9656056
• MDR Text Key: 177350383
• Report Number: 3013756811-2020-10669
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007318
• UDI-Public: 00853052007318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 1000911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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; Required Intervention
• Patient Age: 54 YR