MAUDE Adverse Event Report: Tandem Diabetes Care Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ 7.9.1; Alternate Controller Enabled Insulin Infusion Pump

Catalog Number	1014936
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced an elevated blood glucose (bg) level of 511 mg/dl; cause unknown.Customer administered a correction injection to address the bg.Recommendation was made to consult a healthcare provider in regards to diabetes management.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: g7 mobile os: ios / ios_iphone 14 pro / 2.9.1 / ios_16.4.1.

• Brand Name: Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ 7.9.1
• Common Device Name: Alternate Controller Enabled Insulin Infusion Pump
• Manufacturer (Section D): Tandem Diabetes Care; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: john connell ; 12400 high bluff drive; san diego, CA 92130 ; +1(858)224-6281
• MDR Report Key: 50159399
• Report Number: 3013756811-2026-141740
• Device Sequence Number: 10576942
• Product Code: QFG
• UDI-Device Identifier: 00389152493671
• UDI-Public: 00389152493671
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K253074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 1014936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2026
• 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: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Unknown