MAUDE Adverse Event Report: Tandem Diabetes Care t:slim X2 Insulin Pump with Control-IQ+ Technology; Alternate Controller Enabled Insulin Infusion Pump

Catalog Number	1014071
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: unknown / unknown / unknown / unknown.
Event or Problem Description
It was reported that pump battery would not charge even when customer used tandem charging cable, tandem wall adapter, and working wall outlet, and issue did not resolve after leaving pump connected for at least 30 minutes; later customer found damage to charging cable and confirmed pump began charging after switching to different cable and wall adapter.There was no adverse impact to the customer¿s blood glucose level.Customer resolved issue by using non-tandem charging cable with tandem wall adapter, was informed that non-tandem charging supplies were not recommended except for troubleshooting, acknowledged guidance, and was arranged to receive replacement charging supplies, with no pump shutdown and no further assistance required.

• Brand Name: t:slim X2 Insulin Pump with Control-IQ+ Technology
• 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: 50946976
• Report Number: 3013756811-2026-177680
• Device Sequence Number: 21216031
• Product Code: QFG
• UDI-Device Identifier: 00389152407111
• UDI-Public: (01)00389152407111(22)1017688(11)251205
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K250792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Catalogue Number: 1014071
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2025
• 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
• Patient Age: 63 YR
• Patient Sex: Female