MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000096

Device Problem Device Alarm System (1012)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Hypoglycemia (1912)

Event Date 04/05/2020

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.

Event Description

It was reported that the customer experienced a blood glucose (bg) level of 40 mg/dl which resulted in customer falling down a flight of cement stairs.Subsequently, customer suffered a concussion, loss of consciousness, tear in carotid artery, fractured c1 and c2 vertebrae, a broken nose and breastbone, fractured ribs, and had significant bruising.The cause of low bg was unknown.The customer alleged that the low bg continuous glucose monitor alert did not declare appropriately; however, although requested the customer was unable to upload pump data for investigation.Subsequently, customer was hospitalized.Bg was treated with intravenous fluids, pain killers, and sugars.Reportedly, the customer was released on (b)(6) 2020 with the issue resolved; however, customer suffered unspecified brain damage and memory loss; loss of mobility, and occasional seizures and tremors.After initial discharge from hospital on (b)(6) 2020, customer subsequently suffered a stroke as a residual effect of initial injuries, and was readmitted to the hospital.Customer was hospitalized on (b)(6) 2020 and was released on (b)(6) 2020.

• 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: 10093809
• MDR Text Key: 192251091
• Report Number: 3013756811-2020-51202
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007301
• UDI-Public: (01)00853052007301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180008
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000898
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 48 YR