iLet Starter Kit - Contact Detach Insulin OnlyRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850050080237), received between Dec 30, 2025 and Jan 26, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN INFUSION SITE CHANGE, THE USER EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE RISING FROM 79 MG/DL TO A PEAK OF 345 MG/DL, REMAINING ABOVE 180 MG/DL FOR APPROXIMATELY TWO HOURS, WITH NO DEVICE ALERTS ABOVE 300 MG/DL FOR OVER 90 MINUTES AND NO EVIDENCE OF SITE LEAKAGE OR BLOOD; THE DEVICE DATE WAS SET INCORRECTLY AND CORRECTED DURING THE CALL, AND CHARTS INDICATED A PERIOD WITHOUT INSULIN FOR OVER TWO HOURS FOLLOWED BY A MEAL. SYMPTOMS INCLUDED HYPERGLYCEMIA WITHOUT DIZZINESS, LOSS OF CONSCIOUSNESS, OR DIABETIC KETOACIDOSIS. OUTCOMES INCLUDED NO USE OF BACKUP THERAPY, NO KETONE TESTING, NO ASSISTANCE REQUIRED, AND NO MEDICAL INTERVENTION OR HOSPITALIZATION. INVESTIGATION INCLUDED REVIEW OF UPLOADED DEVICE REPORTS AND USER GUIDANCE ON CORRECTING DEVICE DATE SETTINGS, ALONG WITH EDUCATION ON MONITORING AND REASSESSMENT. INVESTIGATION OF THIS CASE REVEALED HYPERGLYCEMIA WITH CAUSE UNCLEAR, WITH CONTRIBUTING FACTORS POSSIBLY INCLUDING THE INCORRECT DEVICE DATE SETTING, A PERIOD WITHOUT INSULIN DELIVERY, AND TIMING OF MEAL INTAKE; NO DEVICE ALARMS WERE TRIGGERED AND NO INFUSION SITE ISSUES WERE DETECTED. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDIN

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 24185795 ↗
• MalfunctionJan 13, 2026Charging Problem

  IT WAS REPORTED THAT THE USER¿S ILET CHARGING PAD APPEARED NOT TO WORK UNTIL THE AGENT GUIDED THE USER TO TRY A DIFFERENT POWER OUTLET, AFTER WHICH THE BATTERY SHOWED CHARGING AND THE PAD¿S GREEN INDICATOR ILLUMINATED. SYMPTOMS INCLUDED NO CLINICAL SYMPTOMS. OUTCOMES INCLUDED NO IMPACT TO HEALTH AND NO ALARMS. INVESTIGATION INCLUDED REMOTE TROUBLESHOOTING AND USER EDUCATION. INVESTIGATION OF THIS CASE REVEALED NORMAL DEVICE FUNCTION AFTER OUTLET CHANGE, CONSISTENT WITH A POWER SOURCE ISSUE RATHER THAN A CHARGER OR PUMP MALFUNCTION. IT WAS CONCLUDED THAT THE CAUSE WAS USER ENVIRONMENT OR SETUP RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063643 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ILET USER EXPERIENCED HYPERGLYCEMIA AFTER ANNOUNCING A MEAL, WITH NO PUMP ALARMS, NO REPORTED INFUSION SET LEAKS, AND CONTINUED HIGH READINGS; THE USER DID NOT CONFIRM WITH A FINGERSTICK AND PLANNED EITHER A SET CHANGE OR A MANUAL INJECTION WITH TEMPORARY PUMP DISCONNECTION AS ADVISED. SYMPTOMS INCLUDED ELEVATED BLOOD GLUCOSE UP TO 380 MG/DL WITHOUT REPORTED KETONES, MEDICAL INTERVENTION, OR ACUTE COMPLICATIONS. OUTCOMES INCLUDED NO HOSPITALIZATION, NO NEED FOR ASSISTANCE, AND NO LONG-TERM HEALTH IMPACT REPORTED. INVESTIGATION INCLUDED COMPLAINT INTAKE, USER EDUCATION ON TROUBLESHOOTING STEPS, AND ASSESSMENT OF PUMP ALERTS AND INFUSION SET STATUS. INVESTIGATION OF THIS CASE REVEALED NO DEVICE ALARMS OR CONFIRMED DELIVERY INTERRUPTION AND NO CONFIRMED COMPONENT FAILURE, SO THE CAUSE OF THE HYPERGLYCEMIA REMAINED UNCLEAR. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS INDETERMINATE.

  Patient problems: Hyperglycemia

  MAUDE report 23930310 ↗