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 Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Shock, Insulin (2264)

Event Date 02/25/2019

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 a low blood glucose (bg) level below 30 mg/dl.The customer alleged that the pump over delivering insulin but was unsure of the reason.The customer was admitted to the emergency room (er) after going into diabetic shock.While at the er, the customer was treated with intravenous glucose shot, and left the er feeling "okay".

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: blood glucose (bg) values below 40 mg/dl were recorded by continuous glucose monitor (cgm) on (b)(6) 2019 from 1:05 am to 2:10 am.Cgm alert 3 (cgm glucose reading below user threshold) and cgm alert 1 (cgm low alert) were annunciated.Prior to the low bg, user requested an 18.75 unit bolus for 225 grams of carbohydrates, which was adjusted to 10 units due to maximum bolus setting.Cgm reading displayed at this time was 225 mg/dl.The user likely entered the 225 grams into the carbohydrates field in the bolus screen in error.Additionally, user made bolus requests while still having insulin on board (iob).There were no erratic basal rate adjustments.The depletion of the estimated volume of insulin in the cartridge was reviewed and compared to the requested delivery.Cartridge was filled with approximately 86 units of usable insulin.Approximately 3.5 units were requested via basal, 11 units via bolus, and 10.5 units during the load process, for a total of 25 units delivered when approximately 65 units remained in the cartridge.Delivering a bolus based on incorrectly entered bg or carbohydrate values could lead to a low bg event.Making bolus requests and still having iob could lead to a low bg event.There is no evidence in the logs that the device over-delivered insulin.There is no evidence that the pump experienced a malfunction or failure.

Event Description

Review of the pump data logs by tandem technical support verified that the basal rate leading up to the event was between 11.5 to 13 units a day and had been suspended around the time of the reported event.Additionally, there was a large food bolus observed at the time of the even which may have been due to the customer transposing the blood glucose (bg) value and carbohydrates amounts when entering values into the pump.

• 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: julia kensick ; 11075 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 8445708
• MDR Text Key: 139620389
• Report Number: 3013756811-2019-13571
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• 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,Followup
• Report Date: 03/22/2019

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: 1000096
• Device Catalogue Number: 1000885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/24/2019
• Supplement Dates FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 66