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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hyperglycemia (1905); Injury (2348)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Device not returned.

Event Description

It was reported that the customer was vomiting and experienced an elevated blood glucose (bg) level of 1,000mg/dl; suspected cause was unknown. Additionally, the customer fell and sustained an injury. Reportedly, the customer was unsure if pump was worn at the time of the incident. The customer required assistance in being taken to the hospital after sustaining an additional fall. The customer was subsequently admitted to the hospital where a feeding tube, as well as manual injections of insulin were used to resolve the issue. Reportedly, the customer was released from the hospital on (b)(6) 2019 with the issue resolved, and no permanent damage.

• 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: 9571348
• MDR Text Key: 174409337
• Report Number: 3013756811-2020-05543
• 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
• Report Date: 01/09/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/09/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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: 01/09/2020 Patient Sequence Number: 1