MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

Model Number 1000096

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a malfunction alarm occurred.During troubleshooting with tandem technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully.Customer¿s blood glucose level was 274 mg/dl.

Manufacturer Narrative

D1, d2b, g4 d1, d2b, g4.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: michael trier ; san diego, CA 92130 ; 8584011451
• MDR Report Key: 16833550
• MDR Text Key: 314407201
• Report Number: 3013756811-2023-55750
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004781
• UDI-Public: (01)00852162004781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• 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: 04/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000096
• Device Catalogue Number: 1000103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/08/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/05/2024
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic