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	Hyperglycemia (1905)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer experienced frequent occlusion alarms over about one month, including alarms during meal and correction doses, which sometimes prevented insulin delivery and led to repeated attempts to clear alarms and resume insulin.Customer¿s blood glucose level reached high range with display reading ¿high,¿ but specific value was not provided.Customer gave correction insulin by injection, reloaded existing cartridge and infusion set, resumed insulin delivery, and worked with support for troubleshooting, after which pump replacement with updated software was recommended and arranged, and customer was instructed on storage, return of pump, and interim insulin therapy.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: 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: 50935234
• Report Number: 3013756811-2026-177004
• Device Sequence Number: 18532734
• Product Code: QFG
• UDI-Device Identifier: 00389152408170
• UDI-Public: 00389152408170
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1004000
• Device Catalogue Number: 1014081
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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: Humalog, Insulin.; Humalog, Insulin.; Unomedical, Infusion Set.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 190 LB