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); Detachment of Device or Device Component (2907)

Patient Problem Hyperglycemia (1905)

Event Date 04/14/2022

Event Type  Injury  

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 the customer experienced an elevated blood glucose (bg) level; cause was not known.Customer's continuous glucose monitor read "high," however, specific bg value was not provided.A correction bolus via the pump was delivered to address bg.Additionally, it was reported that an o-ring was on the pneumatic tap.The customer was able to remove the o-ring from the pump and successfully reload the existing cartridge and resumed insulin therapy.It was also reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process.Reportedly, the cartridge was changed to address the issue.Customer's blood glucose level was 303 mg/dl.

• 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: 14219306
• MDR Text Key: 290161986
• Report Number: 3013756811-2022-43122
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00085006613373
• UDI-Public: 0085006613373
• 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
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1005698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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): Other
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic