MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

Model Number	1000096
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per tandem's user guide: your t:slim x2 pump is watertight to a depth of 3 feet for up to 30 minutes (ipx7 rating), but it is not waterproof.The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
Event or Problem Description
It was reported that customer dropped pump in water and a malfunction alarm occurred.Customer's blood glucose level was 256 mg/dl.Reportedly, the customer reverted to manual injections for insulin therapy.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Common Device Name: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• MDR Report Key: 8847063
• Report Number: 3013756811-2019-45517
• Device Sequence Number: 2093783
• Product Code: LZG
• UDI-Device Identifier: 00852162004781
• UDI-Public: (01)00852162004781
• Combination Product (Y/N): N
• PMA/510(K) Number: K111210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 79