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

Model Number	1004000
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer experienced repeated occlusion alarms on tandem mobi pump.There was no adverse impact to the customer¿s blood glucose level.Customer primed tubing, changed infusion set and cartridge, and was able to resume insulin, and later changed supplies again but continued to experience ongoing occlusion issues; cts advised customer to monitor and seek additional help if alarms recurred, then arranged replacement pump with updated software, provided instructions for storage and return of problematic pump, and guided customer on setting up replacement pump and connecting continuous glucose monitor, while also following up by sms to obtain supply information before closing case.The customer continued to use the pump for insulin therapy and has an alternate method of insulin therapy available if necessary.
Additional Manufacturer Narrative
In use at the time of the event: cgm model: unknown mobile os: ios / ios_iphone 13 / ios_16.1.1.

• 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: 50949129
• Report Number: 3013756811-2026-177865
• Device Sequence Number: 16039430
• Product Code: QFG
• UDI-Device Identifier: 00389152365510
• UDI-Public: (01)00389152365510(22)1013457(11)241224
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233044
• 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 Model Number: 1004000
• Device Catalogue Number: 1013655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Lispro - Insulin; Tandem - Cartridge; Unomedical - Infusion Set
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 155 LB