MAUDE Adverse Event Report: TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP

Model Number 004628-005

Device Problems Incorrect Measurement (1383); Insufficient Flow or Under Infusion (2182)

Patient Problem Inflammation (1932)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.

Event Description

It was reported that the pump insulin gauge was inaccurate as it changed from 200 to 0 units.Customer changed the cartridge to resolve the issue.A resume pump alarm and change cartridge notification were reported to have occurred; however, customer did not provide further information regarding the alarm and notification.Customer's blood glucose (bg) was 250-500 mg/dl.Customer went to a diabetic clinic and was advised to go to the emergency room.Customer was admitted to the hospital with a bg of 398 mg/dl and was treated with intravenous fluids and insulin.Elevated bg resolved; however, customer's pancreas was inflamed.Customer was discharged on (b)(6) 2019.Customer alleged pump was not delivering insulin properly.Pump system check with tandem technical support (cts) found a decreased amount of insulin exiting the tubing.Customer reverted to using manual injections for insulin therapy.Although multiple attempts were made by cts to confirm pancreas issue had been resolved and to obtain additional information regarding the event, customer did not reply.

• Brand Name: T:FLEX INSULIN DELIVERY SYSTEM
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: julia kensick ; 11075 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 8768836
• MDR Text Key: 150304541
• Report Number: 3013756811-2019-39585
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004569
• UDI-Public: (01)00852162004569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 004628-005
• Device Catalogue Number: 007473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/15/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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: 53 YR