MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2, BASAL IQ, MG/DL; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1002717

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/15/2021

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 a low blood glucose (bg) level of 27-64 mg/dl resulting in loss of consciousness and a hospitalization.Suspected cause was due to customer delivering too much insulin via a bolus when the customer was already at a low bg of 64 mg/dl.Customer consumed 4 grams of carbohydrates to address bg.Additionally, the customer was treated with human insulin.Customer was released from the hospital on (b)(6) 2021, with no permanent damage and was provided additional training in regards to bolus deliveries.

• Brand Name: T:SLIM X2, BASAL IQ, MG/DL
• 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: 11636518
• MDR Text Key: 244491970
• Report Number: 3013756811-2021-37073
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007998
• UDI-Public: (01)00853052007998
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1002717
• Device Catalogue Number: 1004219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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): Hospitalization; Life Threatening; Required Intervention