InjuryQFG

INSULIN PUMP

Received Jun 4, 2026 · Event occurred May 27, 2026

Report MW5188949 · MDR key 25392139

Device

Generic name

Alternate Controller Enabled Insulin Infusion Pump

Manufacturer

Tandem Diabetes Care, Inc.

Patient

46 YR · Female

Hyperglycemia
Elevated ketones/Diabetic Ketoacidosis

Narrative

Description of Event or Problem

INSULIN PUMP (TANDEM MOBI) MALFUNCTIONED CAUSING HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS REQUIRING EMERGENCY ROOM VISIT RESULTING IN BEING ADMITTED TO HOSPITAL FOR 2 DAYS.