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 Problem Date/Time-Related Software Problem (2582)

Patient Problem Hyperglycemia (1905)

Event Date 04/04/2022

Event Type  Injury  

Event Description

It was reported that the customer experienced an elevated blood glucose (bg) level of 410-411 mg/dl and moderate ketones resulting in a hospitalization.A correction bolus was delivered to address the bg prior to the hospitalization.While hospitalized, the customer was treated with insulin and saline delivered intravenously.At the time of the event, no issues were identified with the cartridge, infusion set tubing, infusion set cannula, or the insulin in use.A pump system check was performed and the only issue identified was that the pump time was incorrect by two hours.The cause of the pump time being incorrect was not known; however, the customer's parent believed the incorrect time on the pump was a big factor resulting in elevated bg levels.The customer was released from the hospital on august 8th with the issue resolved and no permanent damage sustained.

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.The tandem user guide states: always make sure that the correct time and date are set on your insulin pump.Not having the correct time and date setting may affect safe insulin delivery.

• 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: 14195266
• MDR Text Key: 289995590
• Report Number: 3013756811-2022-39512
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1007420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Ethnicity: Non Hispanic