Omnipod UST400 (REF 14500-5A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 816 adverse event reports that list this exact device (DI 10385081140003), received between Oct 28, 2016 and Jul 3, 2025 — classified as 12 deaths, 650 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (368 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 816 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Failure to Power Up; Failure to Power Up

  THE PATIENT EXPERIENCED A FAILURE OF HER PERSONAL DIABETES MANAGER (PDM) ON (B)(6) 2025, WHICH LED TO HER REMOVING THE POD AS IT WOULDN'T TURN BACK ON EVEN AFTER A BATTERY CHANGE. THIS MALFUNCTION CAUSED HER TO SEEK MEDICAL ATTENTION AT THE HOSPITAL ON (B)(6) 2025, DUE TO SYMPTOMS INCLUDING NAUSEA, VOMITING, HIGH BLOOD GLUCOSE LEVELS, HEADACHE, CONFUSION, AND DIZZINESS. SHE WAS DIAGNOSED WITH HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS (DKA) AND RECEIVED TREATMENT INVOLVING AN INSULIN DRIP, INTRAVENOUS (IV) FLUIDS, AND MEDICATION FOR HER SYMPTOMS. SHE WAS HOSPITALIZED FOR THREE DAYS, FROM (B)(6) 2025. THE PATIENT DID NOT HAVE A BACKUP INSULIN DELIVERY METHOD AT THE TIME OF THE INCIDENT.

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

  MAUDE report 22398986 ↗
• InjuryMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THEY EXPERIENCED A DIABETIC SEIZURE WITH A BLOOD GLUCOSE (BG) READING OF 29 MG/DL, LEADING TO A HOSPITAL VISIT LAST FRIDAY. AT THE HOSPITAL, THE PATIENT'S BG LEVEL WAS 80 MG/DL. THE ISSUE WAS RELATED TO THE PERSONAL DIABETES MANAGER (PDM), WHICH DISPLAYED ERROR 3. AFTER POWER CYCLING THE PDM TWICE, IT STARTED WORKING CORRECTLY. THE MOTHER, SPEAKING ON BEHALF OF HER SON, CONFIRMED THE PDM WAS FUNCTIONING BUT ENDED THE CALL BEFORE PROVIDING DETAILED INFORMATION ABOUT THE MEDICAL EVENT. THE AGENT DOCUMENTED THE ISSUE AND ADVISED A POWER CYCLE, WHICH RESOLVED THE PDM ERROR. THE PATIENT WAS NOT AVAILABLE TO ANSWER FURTHER QUESTIONS.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 21700725 ↗
• InjuryFeb 11, 2025Insufficient 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 764 MG/DL WHILE WEARING THE POD. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, NAUSEA AND VOMITING. THE PATIENT REPORTS BEING UNABLE TO APPLY A POD DUE TO THEIR CONTROLLER WOULD NOT TURN ON. ONCE AT THE HOSPITAL THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AS WELL AS AN INSULIN DRIP. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 3 DAYS.

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

  MAUDE report 21355838 ↗
• DeathJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SOCIAL MEDIA POST REPORTED: "OMNIPOD KILLED MY SON BACK IN 2016". THE SOCIAL MEDIA POST DID NOT REPORT ANY DETAILS, INCLUDING PATIENT OR DEVICE INFORMATION. CONTACT DETAILS FOR THE REPORTER WERE ALSO NOT INCLUDED IN THE INITIAL REPORT. INSULET RESPONDED TO THE SOCIAL MEDIA POST REQUESTING FURTHER INFORMATION, HOWEVER AT THE TIME OF THIS REPORT ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED. THIS CASE WILL BE REASSESSED IF NEW INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19799654 ↗
• InjuryJul 22, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS. IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 429 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTS THEIR PERSONAL DIABETES MANAGER (PDM) SCREEN WAS BLACK. NO FURTHER INFORMATION COULD BE PROVIDED AS TO THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 19792474 ↗
• InjuryJun 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT VISITED THE ER (EMERGENCY ROOM) WITH HYPERGLYCEMIA. THE PATIENT'S GUARDIAN REPORTED THAT THE PDM (PERSONAL DIABETES MANAGER) PRESENTED WITH A HAZARD ALARM, THAT THEY WERE UNABLE TO RESET IN ORDER TO DELIVER INSULIN VIA THE POD. THE GUARDIAN REPORTED THE PATIENT DID NOT HAVE AN ALTERNATIVE FORM OF INSULIN DELIVERY. NO FURTHER INFORMATION IS AVAILABLE. THREE DUE DILIGENCE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS.

  Patient problems: Hyperglycemia

  MAUDE report 19499040 ↗
• InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND BLOOD GLUCOSE (BG) VALUES THAT REACHED OVER 250 MG/DL. FOR TREATMENT, THE PATIENT WAS GIVEN INSULIN AND DIAGNOSTIC TESTS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 19288908 ↗
• InjuryApr 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES THAT DROPPED TO 45 MG/DL. NO TREATMENT INFORMATION WAS GIVEN. THE PATIENT IS CURRENTLY IN THE HOSPITAL.

  Patient problems: Hypoglycemia

  MAUDE report 19034455 ↗
• InjuryMar 25, 2024Insufficient 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 300 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTS REMOVING THEIR POD DUE TO THEIR PERSONAL DIABETES MANAGER (PDM) NOT TURNING ON. ONCE AT THE HOSPITAL THE PATIENT WAS PRESCRIBED METFORMIN. THE PATIENT WAS AT THE HOSPITAL FOR 45 MINUTES.

  Patient problems: Hyperglycemia

  MAUDE report 18968389 ↗
• InjuryMar 11, 2024Insufficient 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 371 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTS THEIR PERSONAL DIABETES MANAGER (PDM) WOULD NOT TURN ON AFTER CHANGING THE BATTERIES AND ATTEMPTING A RESET. THE PATIENT REPORTS RECEIVING A HAZARD ALARM TO REMOVE THE POD PRIOR TO THEIR PDM NOT TURNING ON. THE PATIENT APPLIED A NEW POD PRIOR TO GOING TO THE HOSPITAL. ONCE AT THE HOSPITAL THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AS WELL AS INSULIN. THE PATIENT REMAINS IN THE HOSPITAL AT THE TIME OF THIS CALL.

  Patient problems: Hyperglycemia

  MAUDE report 18877571 ↗
• InjuryMar 8, 2024Insufficient 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 400 MG/DL. THE PATIENT REPORTED THAT THE CONTROLLER STOPPED WORKING FOR THREE DAYS. SYMPTOMS REPORTED INCLUDE VOMITING AND SEVERE TOOTH PAIN. THE PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL. ONCE AT THE HOSPITAL THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AS WELL AS INSULIN. THE PATIENT WAS PRESCRIBED CLINDAMYCIN (150 MG) TO BE TAKEN 3 TIMES A DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 7 HOURS.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 18865334 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 108 MG/DL. THE PATIENT REPORTED THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL. AS TREATMENT, THE POD WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859338 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 23 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS STILL RECEIVING INSULIN.

  Patient problems: Hypoglycemia

  MAUDE report 18858980 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS STILL RECEIVING INSULIN. WHEN PATIENT LOOKED AT THE HISTORY IT SHOWED 1.2 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858802 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 20 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL.

  Patient problems: Hypoglycemia

  MAUDE report 18858743 ↗
• MalfunctionMar 7, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL DROPPED TO 111 MG/DL. THE PATIENT REPORTED THAT THEY TRIED TO SUSPEND THEIR INSULIN BUT WAS UNSUCCESSFUL. AS TREATMENT, THE PATIENT DRANK A GLASS OF ORANGE JUICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858547 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY THE PATIENT THAT THE PDM (PERSONAL DIABETES MANAGER) WAS GIVING A BOLUS WHEN THEY HAVE NOT PUT IN THE SETTINGS. THE PDM STATED THAT IT WAS GOING TO GIVE A BOLUS OF 5.6 UNITS AND THEY DID NOT HAVE A CHOOSE TO DECLINE THE BOLUS. THE BLOOD GLUCOSE LEVELS REACHED LESS THAN 70 MG/DL.

  Patient problems: Hypoglycemia

  MAUDE report 18827511 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY THE PATIENT THAT THE PDM (PERSONAL DIABETES MANAGER) GAVE A BOLUS 1.60 UNITS AND THEN AGAIN ANOTHER BOLUS FOR THE AMOUNT OF 2.40 UNITS WHICH WAS NOT COMMANDED. THE BLOOD GLUCOSE LEVELS REACHED 53 MG/DL.

  Patient problems: Hypoglycemia

  MAUDE report 18827492 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  A PATIENT REPORTS THEIR PERSONAL DIABETES MANAGER (PDM) HAD DELIVERED AN UNCOMMANDED BOLUS. THE PATIENT REPORTS AT 11:51 AM BEING DELIVERED AN UNCOMMANDED BOLUS OF 5.40 UNITS OF INSULIN. THE PATIENTS REPORTS THEIR BLOOD GLUCOSE LEVEL HAD DECREASED TO 45 MG/DL. AS TREATMENT THE PATIENT DECREASED THE BASAL PROGRAM BY 50% FOR 2 HOURS AND HAD TAKEN GLUCOSE.

  Patient problems: Hypoglycemia

  MAUDE report 18826610 ↗
• MalfunctionMar 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT THAT SAYS THEIR BG LEVELS WAS "LOW" (EXACT BG LEVELS WAS NOT PROVIDED). A REVIEW OF THE PATIENT'S HISTORY IN THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) FOUND AN UNCOMMANDED INSULIN DELIVERY BOLUS OF 1 UNIT OF INSULIN AT 2:08 AM WAS GIVEN WITHOUT THE PATIENT'S ACTION.

  Patient problems: Hypoglycemia

  MAUDE report 18826344 ↗
• MalfunctionFeb 16, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) MELTED. NO INJURIES WERE REPORTED DUE THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727600 ↗
• InjuryDec 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND BLOOD GLUCOSE (BG) VALUES THAT REACHED 405 MG/DL. THE PATIENT WAS NAUSEOUS AND VOMITING. FOR TREATMENT, THE PATIENT WAS GIVEN FLUIDS, ANTI-NAUSEA MEDICATION, AND INSULIN. THE PATIENT WAS DISCHARGED AFTER 1 DAY. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM.

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

  MAUDE report 18364511 ↗
• InjuryDec 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT REPORTS WHILE IN THE HOSPITAL THEIR PERSONAL DIABETES MANAGER (PDM) HAD GOT LIQUID SPILLED ON IT AND WOULD NO LONGER TURN ON WHICH WAS REPORTED IN A PRIOR COMPLAINT. NO FURTHER INFORMATION IS AVAILABLE AS TO THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 18330272 ↗
• InjuryNov 30, 2023Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES REACHED OVER 250 MG/DL. THE PATIENT STATED SHE FELT REALLY BAD, HEADACHE AND REALLY CONFUSED. FOR TREATMENT, THE PATIENT WAS PRESCRIBED INSULIN INJECTIONS. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM.

  Patient problems: Cognitive Changes; Headache; Hyperglycemia; Nausea

  MAUDE report 18237061 ↗
• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE NOT GIVEN WHILE WEARING THE POD FOR AN UNKNOWN AMOUNT OF TIME. THE PATIENT REPORTED THAT THEY WERE VOMITING. THE PATIENT WAS TREATED WITH INTRAVENOUS, IV(INTRAVENOUS) INSULIN DRIP, AND ZOFRAN. THE PATIENT WAS STILL AT THE ER (EMERGENCY ROOM).THE PATIENT MENTIONED THAT THE LOST THERE PDM (PERSONAL DIABETES MANAGER) A FEW DAYS AGO.

  Patient problems: Vomiting

  MAUDE report 18231005 ↗