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

Model Number	004628-005
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per tandem's user guide, "change your cartridge every 48-72 hours as recommended by your healthcare provider" 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 and evaluation is performed.
Event or Problem Description
It was reported that intermittently, the pump did not deliver basal insulin as intended.There was no reported adverse impact to the customer¿s blood glucose level.Tandem technical support reviewed pump data logs and found that the customer loaded a total of four cartridges while using the pump over a period of four months.Reportedly, the customer declined additional troubleshooting and reverted to manual injections for insulin therapy.

• 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: 10275333
• Report Number: 3013756811-2020-76194
• Device Sequence Number: 2398777
• Product Code: LZG
• UDI-Device Identifier: 00852162004606
• UDI-Public: (01)00852162004606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 004628-005
• Device Catalogue Number: 007666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 102