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

Model Number 1002717

Device Problems Filling Problem (1233); Incorrect Measurement (1383)

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

Event Date 03/15/2023

Event Type  Injury  

Event Description

It was reported that a minimum fill notification occurred after the user filled the cartridge with 200 units of insulin during the load sequence.Customer¿s blood glucose level was 522-523 mg/dl; cause was due to no insulin being delivered by pump.Reportedly, customer intentionally delivered insulin via fill tubing process while connected to the site to address bg level.The cartridge was reloaded to resolve the issue.Multiple attempts were made to follow up with the customer regarding the reported issue; however, no response from the customer was received.No additional patient or event information was available.

Manufacturer Narrative

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

• 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: michael trier ; 8584011451
• MDR Report Key: 16683456
• MDR Text Key: 312711669
• Report Number: 3013756811-2023-46970
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1007420
• Device Lot Number: W0348530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: NOVOLOG / NOVORAPID
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic