MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number 1002717

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

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.

Event Description

It was reported that the customer experienced low blood glucose (bg) levels throughout the day ranging between 23-109 mg/dl resulting in the customer fainting; cause was not known.Customer consumed food and high sugar juice to address bg.Customer was taken to the emergency room (er) via an ambulance for treatment.While in the ambulance customer was treated with glucose gel.At the er, customer consumed sandwiches and juice to address bg.Customer received intravenous saline, juice, food, nausea medication and pain relief as treatment.No damage was observed with the cartridge, infusion set tubing or cannula.During a follow-up, it was confirmed that the low bg was caused by the customer building up antibodies to novo insulin.Customer reverted to alternate insulin therapy for diabetes management.Customer was released from the hospital on (b)(6) 2019.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 9451568
• MDR Text Key: 170271578
• Report Number: 3013756811-2019-85795
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

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 Operator: Lay User/Patient
• Device Model Number: 1002717
• Device Catalogue Number: 1002684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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; Life Threatening; Required Intervention