MAUDE Adverse Event Report: TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP

Model Number	004628-005
Medical Device Problem Codes	Pumping Stopped (1503); Date/Time-Related Software Problem (2582)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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.Additionally, it was reported that the pump time was incorrect, cause was unknown.During troubleshooting with tandem technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully.Customer¿s blood glucose level was 278 mg/dl.

• Brand Name: T:FLEX INSULIN DELIVERY SYSTEM
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• MDR Report Key: 12594466
• Report Number: 3013756811-2021-112182
• Device Sequence Number: 3370171
• Product Code: LZG
• UDI-Device Identifier: 00852162004606
• UDI-Public: (01)00852162004606
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: No Information
• Device Model Number: 004628-005
• Device Catalogue Number: 007666
• 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: 09/30/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 107