MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G4 SYSTEM; INSULIN PUMP

Model Number 4628-003

Device Problem Partial Blockage (1065)

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

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

Per the cartridge instructions for use: "replace the cartridge every 48 hours if using humalog; every 72 hours if using novolog¿ no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that customer saw white crystallization coming out of the fill port as well as the cartridge tubing.Customer experienced moderate levels of ketones and an elevated blood glucose (bg) level of over 600mg/dl and was subsequently hospitalized.Reportedly, the ketone level was not considered dangerous by the healthcare provider.In an attempt to resolve elevated bg, the customer administered a bolus, manual injections, and tested for ketones.While at the hospital, the customer was treated with insulin drip, and fluids.The customer was released from the hospital approximately two days later with no permanent damage and issue resolved.The customer alleged that the insulin crystallization was the cause of elevated bg.Reportedly, customer had been using the same insulin, cartridge, and infusion sets for a week.Tandem technical support advised the customer to only use pump supplies for up to 3 days as using for a longer time is considered off label.

• Brand Name: T:SLIM G4 SYSTEM
• Type of Device: INSULIN PUMP
• 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: 9859737
• MDR Text Key: 184263213
• Report Number: 3013756811-2020-31457
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00852162004408
• UDI-Public: (01)00852162004408
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4628-003
• Device Catalogue Number: 006194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 31 YR