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

Model Number 004628

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

Patient Problems Fall (1848); Head Injury (1879); Hypoglycemia (1912)

Event Date 04/21/2022

Event Type  Injury  

Event Description

It was reported that the customer went to the emergency room (er) due to blood glucose (bg) level of 60 mg/dl, and a seizure resulting in customer falling and hitting head.Reportedly, the cause was unknown; however, customer misread bg level via fingerstick and did not believe they were experiencing a low bg.No information was provided regarding treatment received.Reportedly, customer left the er the same day with the issue resolved and no permanent damage.System check with tandem technical support confirmed the pump was functioning as intended.

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

• Brand Name: T:SLIM INSULIN DELIVERY 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: 14429946
• MDR Text Key: 291943781
• Report Number: 3013756811-2022-48458
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004545
• UDI-Public: (01)00852162004545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111210
• 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: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 004628
• Device Catalogue Number: 007262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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: 16 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic