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); Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Visual Impairment (2138)

Event Date 08/01/2019

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 intermittent low and high blood glucose (bg) levels. The customer provided a bg range of 20-450 mg/dl, however, declined to provide the bg value for most recent elevated bg and reported experiencing large ketone levels identified as dangerous. Reportedly, customer treated low bg with glucagon shot and glucose gel. Customer's husband delivered glucose gel and glucagon shot to assist with low bg. Elevated bg was treated with insulin via bolus using the pump and manual injection. The customer alleged that the pump was not delivering the correct amount of basal insulin; however acknowledged that elevated bg levels also occurred due to over correction for low bg. Reportedly, customer sustained "floaters" in the left eye. The customer reverted to manual injections for insulin therapy.

• 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: 9088626
• MDR Text Key: 159228006
• Report Number: 3013756811-2019-58601
• Device Sequence Number: 1
• Product Code: OZO
• 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

• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 09/19/2019 Patient Sequence Number: 1