MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number 1000096

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

Patient Problems Hyperglycemia (1905); Myocardial Infarction (1969)

Event Date 06/14/2020

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 was hospitalized on (b)(6) 2020 due to an elevated blood glucose (bg) level (808 mg/dl) caused by the customer incorrectly programming pump settings.Reportedly, the elevated bg level caused the customer to have a heart attack.While in the hospital, the customer was treated with intravenous insulin and fluids.Customer was released from the hospital on (b)(6) 2020 with difficulty walking due to being bedridden while in the hospital.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 10407931
• MDR Text Key: 202939620
• Report Number: 3013756811-2020-83891
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007981
• UDI-Public: (01)00853052007981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1003808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 65