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 Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.

Event Description

It was reported that the pump fell and delivered an unintended bolus, causing the customer's blood glucose (bg) to drop to 45 mg/dl.Customer resolved bg and reverted to an alternate form of insulin therapy.No further information was provided.

Manufacturer Narrative

The failure investigation has been completed.Based on the analysis, the alleged issue could not be verified; however, a different issue was identified.

Manufacturer Narrative

Tandem quality engineer evaluated pump data and concluded the following: there is no evidence that the pump experienced a malfunction or failure.A3.

• 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: 12813663
• MDR Text Key: 280767793
• Report Number: 3013756811-2021-123026
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007998
• UDI-Public: (01)00853052007998
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1004219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/21/2022
• 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: NOVOLOG
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic