MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000354

Device Problem Pumping Stopped (1503)

Patient Problems Fall (1848); Hyperglycemia (1905)

Event Date 02/20/2022

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 and evaluation is performed.

Event Description

It was reported that an unspecified malfunction alarm occurred. Customer¿s blood glucose level (bg) was over 300 mg/dl. Reportedly, customer fell and hit their head and the customer went to the hospital and was subsequently admitted to the intensive care unit. The customer received intravenous fluids of saline and insulin. Customer reverted to an alternate method of insulin therapy. Multiple contact attempts were made by tandem technical support to obtain additional information regarding the issue; however, the customer did not respond.

• 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: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 13825683
• MDR Text Key: 287527721
• Report Number: 3013756811-2022-28922
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201214
• 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: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000354
• Device Catalogue Number: 1006379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: 03/19/2022 Patient Sequence Number: 1