Tandem Mobi Insulin Pump with Control-IQ+ Technology
Received Jul 31, 2026 · Event occurred Jun 27, 2026
Report 3013756811-2026-137833 · MDR key 50094103
Device
Generic name
Alternate Controller Enabled Insulin Infusion Pump
Manufacturer
Tandem Diabetes CareModel number
1004000Catalog number
1013655
Product problems
- Obstruction of Flow
Patient
9 YR · Unknown
- Hyperglycemia
Narrative
Description of Event or Problem
It was reported that ongoing intermittent occlusion alarms occurred. The customer's blood glucose level was "High", although specific value was not provided on (B)(6) 2026. The elevated BG was addressed by a correction injection via manual insulin therapy. No third party assistance was required. The customer changed the infusion set and cartridge to resolve the occlusions. 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.