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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fatigue (1849); Hyperglycemia (1905)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

The pump user guide states: your pump can stop insulin delivery and alert you (or whoever is with you) if there has been no interaction with the pump within a specified period of time.The default for this alarm is pre-set to 12 hours.You can set it anywhere between 5 and 24 hours, or off.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 blood glucose (bg) level of an alleged 10,000mg/dl, a large ketone level identified as dangerous by healthcare provider, two strokes, pneumonia, and a diabetic coma.The cause of elevated bg was unknown.The customer went to the emergency room and was subsequently hospitalized.Treatment was administered through manual injections of insulin, antibiotics and customer was put on ventilator.Reportedly, the customer was released on (b)(6) 2021 with the issue resolved; however customer has numbness and weakness in extremities.Pump data review by tandem technical support confirmed the pump was functioning as intended; however customer received an auto off alarm.

• 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: 11778940
• MDR Text Key: 249115205
• Report Number: 3013756811-2021-48306
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 1005698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/14/2021
• 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
• Treatment: INSULIN TYPE: NOVOLOG / NOVORAPIDINFUSION SET PRO
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR