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 Fainting (1847); Hypoglycemia (1912)

Event Date 08/16/2020

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 low blood glucose (bg) level of 32 mg/dl; cause was not known.Reportedly, the customer fainted and subsequently had scraped knees.Customer consumed carbohydrates to address bg.Recommendation was made to consult with a healthcare provider to discuss diabetes management.

Manufacturer Narrative

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

• 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
• MDR Report Key: 10491388
• MDR Text Key: 205643494
• Report Number: 3013756811-2020-91938
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00085006613373
• UDI-Public: 0085006613373
• Combination Product (y/n): N
• PMA/PMN Number: P180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 1002717
• Device Catalogue Number: 1005698
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/16/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR