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

Model Number	004628
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced a blood glucose (bg) level of 38 mg/dl.Reportedly the pump delivered a bolus without user input and that there was a settings issue.Reportedly the customer fell off the bed due to passing out, injured their legs and arms and had a seizure.The customer went to the emergency room and was subsequently hospitalized in the intensive care unit.Bg was treated with intravenous insulin and saline.Reportedly, the customer was released on (b)(6) 2022 with the issue resolved and no permanent damage.System check with tandem technical support confirmed the pump was functioning as intended.
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

• Brand Name: T:SLIM INSULIN DELIVERY SYSTEM
• Common Device Name: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 15157724
• Report Number: 3013756811-2022-82270
• Device Sequence Number: 5196140
• Product Code: LZG
• UDI-Device Identifier: 00852162004552
• UDI-Public: (01)00852162004552
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111210
• 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): 07/13/2022

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 Model Number: 004628
• Device Catalogue Number: 007264
• 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: 07/13/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic