inforMED
InjuryQFG

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

Model number

1004000

Catalog 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.