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

Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tandem mobi pump battery would not charge even though customer used standard charging pad, cable, wall adapter, and confirmed wall outlet was working, and initial attempts including leaving pump on charging pad for 30 minutes did not resolve issue.There was no adverse impact to the customer¿s blood glucose level because pump was not actively set up.Customer tried different charging cable without success, then tried different charging pad which allowed pump to begin charging; customer ultimately continued using original charging supplies, and no further assistance was required.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown.Mobile os: unknown / unknown / unknown.

• Brand Name: Tandem Mobi 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: 50946938
• Report Number: 3013756811-2026-177674
• Device Sequence Number: 9624020
• Product Code: QFG
• UDI-Device Identifier: 00389152480114
• UDI-Public: 00389152480114
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K240309
• 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
• 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: 09/20/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2026
• 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
• Patient Age: 49 YR
• Patient Sex: Female