MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G4 SYSTEM; INSULIN PUMP

Model Number	4628-003
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a malfunction alarm occurred.During troubleshooting with tandem technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully.Customer¿s blood glucose value was 170 mg/dl.

• Brand Name: T:SLIM G4 SYSTEM
• Common Device Name: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• MDR Report Key: 9282513
• Report Number: 3013756811-2019-74297
• Device Sequence Number: 2132552
• Product Code: OYC
• UDI-Device Identifier: 00852162004750
• UDI-Public: 00852162004750
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: 4628-003
• Device Catalogue Number: 008542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR