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 Problems Filling Problem (1233); Incorrect Measurement (1383); Mechanical Problem (1384)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

It was reported that a cartridge change error occurred.The customer reloaded the cartridge to resolve the issue.Additionally, it was reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process.It was also reported that the insulin gauge was inaccurate.The customer reverted to an alternate method of insulin therapy.Customer¿s blood glucose level was 215 mg/dl.

Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be submitted upon completion of the evaluation.

Manufacturer Narrative

The failure investigation has been completed.Based on the analysis, the alleged load fill tubing and fill estimate issues could not be verified while the alleged cartridge change error issue was verified in the pump logs; however, no failure was identified.

• 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: 15372994
• MDR Text Key: 304923015
• Report Number: 3013756811-2022-94280
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613731
• UDI-Public: 00850006613731
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000354
• Device Catalogue Number: 1006379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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
• Treatment: INSULIN TYPE: HUMALOG
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic