Omnipod UST400 (REF 18900-5A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10385081120012), received between Apr 13, 2023 and Feb 13, 2026 — classified as 17 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Intermittent Loss of Power

  THE PATIENT¿S PARENT REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2026, DUE TO ELEVATED BLOOD GLUCOSE (BG) LEVELS DISPLAYED AS ¿HIGH,¿ INDICATING LEVELS ABOVE 400 MG/DL. NO SPECIFIC BG LEVELS WERE PROVIDED. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AT THE HOSPITAL. REPORTED SYMPTOMS INCLUDED DEHYDRATION AND VOMITING. THE PARENT EXPLAINED THAT A POD WAS NOT BEING WORN AT THE TIME OF THE MEDICAL EVENTS BECAUSE THE OMNIPOD CONTROLLER WAS NOT FUNCTIONING. THE PARENT HAD CONTACTED PRODUCT SUPPORT ON JANUARY 15 TO REPORT THAT AFTER INSERTING NEW BATTERIES, THE CONTROLLER REPEATEDLY POWERED ON AND OFF WITHOUT DISPLAYING AN ERROR CODE OR ALARM AND COULD NOT BE RESET. DUE TO THE NONFUNCTIONAL CONTROLLER, THE PATIENT WAS UNABLE TO CONTINUE OMNIPOD THERAPY AND WAS REPORTEDLY AFRAID TO TAKE MANUAL INSULIN INJECTIONS. THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSIONS AND ANTI-NAUSEA MEDICATION DURING HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2026.

  Patient problems: Dehydration; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 24339702 ↗
• InjuryMay 7, 2025Reset Problem; Reset Problem

  IT WAS REPORTED PERSONAL DIABETES MANAGER (PDM) WAS NOT FUNCTIONING PROPERLY, DISPLAYING ONLY A WHITE SCREEN. AS A RESULT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS OVER 350 MG/DL AND HE HAD TO ADMINISTER INSULIN INJECTIONS MANUALLY. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS (DKA). SYMPTOMS REPORTED INCLUDE VOMITING. TREATMENT INCLUDED INTRAVENOUS FLUIDS, INSULIN, MAGNESIUM AND POTASSIUM. THE PATIENT REMAINED HOSPITALIZED AT THE TIME OF REPORTING.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 21981519 ↗
• InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT REPORTS THEY HAD RECEIVED A MEMORY CORRUPTION HAZARD ALARM ON THEIR PERSONAL DIABETES MANAGER IN WHICH HAD CLEARED OUT THE PATIENTS SETTINGS. THE PATIENT REPORTS THEIR BLOOD GLUCOSE READ HIGH (>400 MG/DL) WHILE WEARING A POD. THE PATIENT REMOVED THE POD BEING WORN PRIOR TO GOING TO THE HOSPITAL. ONCE AT THE HOSPITAL THE PATIENT HAD LAB WORK ADMINISTERED. THE PATIENT WAS TREATED WITH AN INSULIN DRIP. THE PATIENT REMAINS IN THE HOSPITAL AT THE TIME OF THIS CALL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 19667639 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 52 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS STILL RECEIVING INSULIN. THE PATIENT STATED THAT THEY FELT LIKE THEY WERE GOING TO PASS OUT AND WAS SWEATING HEAVILY.

  Patient problems: Hypoglycemia

  MAUDE report 18859238 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO LESS THAN 70 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS STILL RECEIVING INSULIN.

  Patient problems: Hypoglycemia

  MAUDE report 18858748 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO BELOW 70 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL.

  Patient problems: Hypoglycemia

  MAUDE report 18858659 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 59 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL.

  Patient problems: Hypoglycemia

  MAUDE report 18858607 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 40 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL. AS TREATMENT, THE PATIENT DRANK 5 CANS OF COCA COLA, ATE HALF PINT OF ICE CREAM AND A CANDY BAR.

  Patient problems: Hypoglycemia

  MAUDE report 18858600 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 45 MG/DL. THE PATIENT REPORTED THE NURSE TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL. AS TREATMENT, THE POD WAS REMOVED.

  Patient problems: Hypoglycemia

  MAUDE report 18858393 ↗
• MalfunctionMar 6, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 40 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPENDED THEIR INSULIN BUT WAS STILL RECEIVING INSULIN. IT WAS ALSO REPORTED THAT THEIR BLOOD GLUCOSE HAS REACHED 400 MG/DL.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 18851818 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY THE PATIENT THAT THE PDM (PERSONAL DIABETES MANAGER) WAS RECEIVING UNEXPECTED BOLUSES. THE PATIENT MENTIONED IT WAS GIVING THEM LOW BLOOD SUGAR BUT BLOOD GLUCOSE LEVELS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827506 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  A PATIENT REPORTS AT 6:46 PM THEIR PERSONAL DIABETES MANAGER (PDM) HAD DELIVERED AN UNCOMMANDED BOLUS OF ALMOST 4 UNITS OF INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826619 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  A PATIENT REPORTS THEIR PERSONAL DIABETES MANAGER (PDM) HAD DELIVERED AN UNCOMMANDED BOLUS. THE PATIENT REPORTS WHILE AT A SCHEDULED DOCTORS APPOINTMENT THEY WERE ADVISED BY THEIR DOCTOR THAT THEIR PDM HAD DELIVERED AN UNCOMMANDED BOLUS RESULTING IN THE PATIENTS GLUCOSE LEVEL DROPPING OT BELOW 70 MG/DL.

  Patient problems: Hypoglycemia

  MAUDE report 18826605 ↗
• InjuryNov 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 500 MG/DL WHILE WEARING THE POD FOR 48 HOURS. ONCE AT THE HOSPITAL THE PATIENT HAD LAB TESTS PERFORMED, THE PATIENT WAS TREATED WITH MANUAL INSULIN SHOTS. THE PATIENTS DOCTOR WAS UNABLE TO GET THEIR CONTROLLER TO WORK AS IT WOULD TURN ON. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY.

  Patient problems: Hyperglycemia

  MAUDE report 18131174 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE HIGH BUT NO LEVELS WERE PROVIDED. SYMPTOMS REPORTED INCLUDE VOMITING, DEHYDRATION AND DIZZINESS. IT WAS ALSO REPORTED THAT THE PDM (PERSONAL DIABETES MANAGER) WOULD NOT TURN ON. THE PATIENT WAS TREATED WITH IV(INTRAVENOUS) AND PRESCRIBED A TABLET TO HELP PREVENT VOMITING BUT DID NOT KNOW THE NAME. THE PATIENT WAS RELEASED THE SAME DAY.

  Patient problems: Dehydration; Dizziness; Vomiting

  MAUDE report 18083545 ↗
• InjuryOct 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 409 MG/DL. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, ACID REFLUX AND GENERAL MALAISE. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, INSULIN, AS WELL AS HEPARIN AND ANTIBIOTICS. THE PATIENT WAS STILL IN THE HOSPITAL AT THE TIME OF THE CALL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Malaise

  MAUDE report 17985978 ↗
• InjuryOct 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WOKE UP IN THE MORNING AND TOOK THE POD OFF BUT FELT VERY SICK SO THEY ADMINISTERED A MANUAL INJECTION. LATER THAT DAY THE PATIENT WENT TO THE HOSPITAL WHICH TURNED INTO DKA. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, NAUSEA AND EXCESSIVE PAIN. THE PATIENT WAS TREATED WITH AN INTRAVENOUS FLUIDS, AND INSULIN.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Pain

  MAUDE report 17883234 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WENT TO THE ER (EMERGENCY ROOM) WITH HYPERGLYCEMIA. THE PATIENT WAS STILL IN THE ER AT THE TIME OF REPORTING. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED >250 MG/DL WHILE WEARING THE POD FOR AN UNKNOWN AMOUNT OF TIME. IT WAS REPORTED BY THE PATIENT THAT THE PDM (PERSONAL DIABETES MANAGER) WAS GLITCHING, VIBRATING, BEEPING AND WAS NOT ABLE TO DELIVER A BOLUS. SYMPTOMS REPORTED INCLUDE COUGHING AND FEELING OVERALL ILL. NO TREATMENT WAS STATED SINCE THE PATIENT WAS STILL IN THE ER. THE POD WAS WORN WHEN SEEKING MEDICAL ATTENTION. ADDITIONAL INFORMATION WAS SOLICITED BUT UNAVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 17861398 ↗
• MalfunctionSep 16, 2023Unintended System Motion; Unintended System Motion

  A PATIENT REPORTS WHILE WEARING A POD THEIR PERSONAL DIABETES MANAGER DELIVERED A NOT COMMANDED BOLUS OF 11 UNITS OF INSULIN FOLLOWED BY ANOTHER 5 UNITS OF INSULIN. THE PATIENT HAD GONE TO THE SCHOOL NURSE DUE TO THEIR BLOOD GLUCOSE LEVEL HAD DROPPED TO 30 MG/DL. THE PATIENT WAS GIVEN GLUCOSE TABLETS, CANDY AND A JUICE BOX .

  Patient problems: Hypoglycemia

  MAUDE report 17762139 ↗
• InjuryAug 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN TO URGENT CARE WITH HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 30 MG/DL. THE PATIENT REPORTED THAT THE PDM WAS NOT WORKING. IT WAS MENTIONED THAT THE PATIENT PASSED OUT. THE PATIENT DID NOT PROVIDE INFORMATION ABOUT HOW THEY WERE TREATED SINCE THEY STATED IT WAS A PRIVATE MATTER AND REFUSED TO GIVE ANY INFORMATION.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 17666266 ↗
• InjuryAug 17, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 347 MG/DL. THE PATIENT HAD GASTROPARESIS, WAS NAUSEOUS AND VOMITING. FOR TREATMENT, THE PATIENT WAS GIVEN INTRAVENOUS (IV) AND WAS PRESCRIBED PROTONIX AT 20 MG TO TAKE 1 PILL A DAY FOR 30 DAYS. THE PATIENT WAS DISCHARGED AFTER 4 DAYS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting

  MAUDE report 17568913 ↗
• InjuryJul 20, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED OVER 900 MG/DL. THE PATIENT WAS NAUSEOUS AND VOMITING. FOR TREATMENT, THE PATIENT WAS GIVEN FLUIDS, INSULIN. ZOFRAN AND DIAGNOSTIC TESTS. THE PATIENT WAS PRESCRIBED ANDROSTERONE 4 MG. THE PATIENT WAS DISCHARGED AFTER 2 DAYS.

  Patient problems: Cognitive Changes; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting

  MAUDE report 17363517 ↗
• InjuryJul 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). SYMPTOMS REPORTED INCLUDE DIARRHEA, VOMITING AND DIFFICULTY BREATHING. THE PATIENT REPORTS THEY WERE UNABLE TO APPLY A POD DUE TO RECEIVING A HAZARD ALARM ON THEIR PERSONAL DIABETES MANAGER (PDM). ONCE AT THE HOSPITAL THE PATIENTS WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AS WELL AS LOW PHOSPHORUS AND MAGNESIUM. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS TREATED WITH BOTH INSULIN AND KEPPRA. THE PATIENT WAS PRESCRIBED INSULIN PENS. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 3 DAYS. THE PATIENT WAS ASSISTED BY INSULET WITH RESETTING THEIR PDM AND ACTIVATING A NEW POD AFTER THIS EVENT.

  Patient problems: Diarrhea; Elevated Ketones/ Diabetic Ketoacidosis; Vomiting

  MAUDE report 17322477 ↗
• InjuryJul 10, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS (DKA) AND HIGH BLOOD GLUCOSE (BG) LEVELS OF 206 MG/DL. THE PATIENT'S OMNIPOD PERSONAL DIABETES MANAGER (PDM) COULD NOT BE TURNED ON, WHICH LED TO THE EVENT. AT THE HOSPITAL, THE PATIENT WAS ADMINISTERED FLUIDS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 17289969 ↗
• InjuryJun 23, 2023Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 454MG/DL. THE PATIENT WAS NAUSEOUS AND VOMITING. FOR TREATMENT, THE PATIENT WAS GIVEN ZOFRAN, FLUIDS AND INSULIN. THE PATIENT WAS STILL IN THE HOSPITAL.

  Patient problems: Hyperglycemia; Nausea; Vomiting

  MAUDE report 17191967 ↗