Omnipod 5 Controller APP M009-S-APRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10385083000336), received between Mar 21, 2025 and Aug 7, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Medication Error” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 23, 2025Open, Classified

   Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

   Z-2016-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Use of Device Problem

  It was reported that the patient went to the emergency room (ER) with hyperglycemia on (b)(6)2026. The patient's blood glucose levels reached over 500 mg/dL while wearing the Pod between 4 and 24 hours. The Pod was worn on the arm. The patient reported having lost the phone where the Omnipod 5 application was manged, which contributed to the elevated blood glucose. Symptoms reported include confusion. The patient was treated with insulin. The patient was discharged the same day. The Pod was removed at the hospital so that the patient could get a magnetic resonance imaging (MRI).

  Patient problems: Cognitive Changes; Hyperglycemia

  MAUDE report 50178156 ↗
• InjuryAug 4, 2026Use of Incorrect Control/Treatment Settings

  It was reported that the patient visited the emergency room with hypoglycemia on (b)(6) 2026. The patient's blood glucose levels declined to 50 mg/dL while wearing the Pod(leg). The patient stated that they had transferred Omnipod 5 therapy settings to a new phone application and may have entered settings incorrectly during the phone change, which resulted in receiving more insulin than expected. Symptoms reported include malaise and fainting. The patient was treated with Intravenous (IV) fluids and was released the same day. The Pod was discarded.

  Patient problems: Hypoglycemia; Malaise; Syncope/Fainting

  MAUDE report 50135553 ↗
• InjuryJun 12, 2026Use of Device Problem; Reset Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026. THE PATIENT¿S IPHONE OMNIPOD APPLICATION GOT RESET AND THEY LOST ALL THEIR CONTROLLER SETTINGS. THEY WERE UNABLE TO SET UP A NEW POD BECAUSE THE SETTINGS WERE MISSING. THE PATIENT'S NURSE SENT THEIR SETTINGS TO THEM, BUT THEY DIDN¿T UNDERSTAND THEM AND WAS DELAYED ENTERING SETTINGS AND THE FOLLOWING DAY SHE NEEDED TO GO TO THE HOSPITAL. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED GREATER THAN 400 MG/DL WHILE WEARING THE POD AN UNSPECIFIED NUMBER OF HOURS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, CHILLS, ¿HEART WAS BEATING REALLY FAST¿, NAUSEA, VOMITING, WEAKNESS, AND FATIGUE. SHE SPENT TWO DAYS IN THE INTENSIVE CARE UNIT AND RECEIVED UNSPECIFIED TREATMENT FOR DKA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026.

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

  MAUDE report 25488484 ↗
• MalfunctionMay 21, 2026Unintended System Motion

  IT WAS REPORTED THAT AN UNCOMMANDED BOLUS WAS DELIVERED ON (B)(6) 2026. THE PATIENT STATED THAT THEY NEVER ADMINISTERED A BOLUS, HOWEVER, HER APPLICATION WAS SHOWING BOLUS READINGS RECORDED FOR THAT DAY. NO FURTHER INFORMATION WAS REPORTED. MULTIPLE ATTEMPTS WERE MADE TO REACH THE REPORTER FOR FURTHER INFORMATION, HOWEVER, WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249886 ↗
• MalfunctionMay 20, 2026Failure to Deliver; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE INCREASED TO 317 MG/DL WHILE WEARING A POD. THE PATIENT EXPLAINED THEY WERE TRYING TO GIVE THEMSELVES AN 11.75-UNIT INSULIN BOLUS BUT DID NOT BELIEVE THEY RECEIVED THE ENTIRE BOLUS. THERE WAS AN UNCONFIRMED BOLUS WHERE THE SCREEN WAS SHOWING EXCLAMATION POINT AND IT WAS TELLING THEM THE UNITS OF INSULIN GIVEN, BUT WHEN THEY CLICKED ON IT, IT SAID, THE LAST BOLUS VALUE IS AN ESTIMATE UNTIL YOUR POD CONFIRMS THAT IT WAS DELIVERED. THEY HAD CHANGED THEIR POD EARLIER THAT MORNING AND THE APPLICATION DID SEEM TO REFLECT THE DISCONTINUATION OF USE OF THE OLD POD BUT HAD CONFLICTING INFORMATION ON THE STATUS OF THE NEW POD. WHEN THEY LOOKED IN HISTORY AND ON EVENTS, THE POD DIDN'T SEEM TO BE ACTIVATED, HOWEVER IF THEY CLICKED ON THE POD IN ANOTHER AREA OF THE SCREEN IT WAS SHOWING ACTIVATED.

  Patient problems: Hyperglycemia

  MAUDE report 25231828 ↗
• MalfunctionMay 4, 2026Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA. THEY STATED THAT THE POD DELIVERED A BOLUS OF 2.1 UNITS OF INSULIN AUTOMATICALLY WITHOUT THEM COMMANDING IT TO. THEIR BLOOD GLUCOSE DECREASED TO APPROXIMATELY 60 MG/DL, PROMPTING THEM TO CONTACT EMERGENCY SERVICES (911). EMERGENCY RESPONDERS ADVISED THE CUSTOMER TO REMOVE THE POD. THE CUSTOMER REPORTED CONSUMING ORANGE JUICE AFTERWARD, FOLLOWING WHICH THEIR BLOOD GLUCOSE LEVELS BEGAN TO IMPROVE. THEY DID NOT REQUIRE TRANSPORT OR REPORT ANY FURTHER TREATMENT.

  Patient problems: Hypoglycemia

  MAUDE report 25074630 ↗
• MalfunctionApr 23, 2026Excess Flow or Over-Infusion; Application Program Problem: Medication Error

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES WHERE THEY WENT TO BOLUS AND INPUT 10 G OF CARBS, BUT THE SYSTEM CHANGED WHAT SHOULD BE DELIVERED FOR THE BOLUS UP TO 10 UNITS OF INSULIN. ADDITIONALLY, THEY PAUSED INSULIN DELIVERY, BUT THEY THOUGHT IT KEPT DELIVERING. THE PATIENT REMOVED THE POD. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT. THE FIRST INSTANCE OF THE SAME THING IS REPORTED IN INSULET CASE REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965745 ↗
• MalfunctionApr 23, 2026Excess Flow or Over-Infusion; Application Program Problem: Medication Error

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES WHERE THEY WENT TO BOLUS AND INPUT 10 G OF CARBS, BUT THE SYSTEM CHANGED WHAT SHOULD BE DELIVERED FOR THE BOLUS UP TO 10 UNITS OF INSULIN. ADDITIONALLY, THEY PAUSED INSULIN DELIVERY, BUT THEY THOUGHT IT KEPT DELIVERING. THIS FIRST INSTANCE OCCURRED WHEN THE PATIENT WAS ON A FLIGHT. THE PATIENT REMOVED THE POD. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION OR TREATMENT. THE SECOND INSTANCE OF THE SAME THING IS REPORTED IN INSULET CASE REFERENCE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965737 ↗
• MalfunctionApr 7, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THAT THE PATIENT WAS TRYING TO PAUSE INSULIN DELIVERY, BUT THE OPTION TO PAUSE WAS MISSING. THE PATIENT WAS USING THE SYSTEM IN MANUAL MODE. NO CHANGES WERE REPORTED TO PATIENT'S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809315 ↗
• MalfunctionApr 1, 2026Excess Flow or Over-Infusion

  THE PATIENT REPORTED THE INABILITY TO PAUSE INSULIN DELIVERY THROUGH THE OMNIPOD APP. THE PATIENT REPLACED THE POD DUE TO DECREASING BLOOD GLUCOSE LEVELS. NO SPECIFIC BLOOD GLUCOSE LEVELS WERE REPORTED. THERE WAS NO MEDICAL INTERVENTION REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758106 ↗
• InjuryJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE PATIENT REPORTED WHILE DRIVING HE EXPERIENCED A SEIZURE DUE TO HYPOGLYCEMIA WITH A SUBSEQUENT VISIT TO THE ER (EMERGENCY ROOM). PATIENT STATED HE DID NOT RECEIVE AN URGENT/CRITICAL LOW GLUCOSE ALARM INDICATING HIS GLUCOSE LEVELS WERE BELOW 60 MG/DL FROM THE OMNIPOD SYSTEM DUE TO HIS CGM (CONTINUOUS GLUCOSE MONITOR) REPORTING HIS GLUCOSE LEVELS TO BE IN THE 80 MG/DL RANGE. HOWEVER, WHEN THE PATIENT ARRIVED AT THE ER, HIS ACTUAL BLOOD GLUCOSE WHEN TESTED WITH A BLOOD GLUCOSE METER WAS 40 MG/DL. THE POD WAS WORN BETWEEN 24 AND 36 HOURS IN THE ARM. THE PATIENT'S WIFE TREATED THE HYPOGLYCEMIA BY PUTTING A SOURCE OF GLUCOSE UNDER HIS TONGUE. AT THE ER, THE PATIENT WAS TREATED WITH ADDITIONAL GLUCOSE, WATER, PEANUT BUTTER, AND CRACKERS. THE PATIENT WAS RELEASED THE SAME DAY ONCE HIS BLOOD GLUCOSE LEVELS HAD STABILIZED. USER DATA LOGS WERE UPLOADED FOR INVESTIGATION.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 22294177 ↗
• MalfunctionJun 17, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT RECEIVED 2 UNSOLICITED BOLUSES FROM THE DEVICE. THE PATIENT REPORTEDLY NOTICED ONE OF THE UNCOMMANDED BOLUSES AFTER HEARING THE POD MAKING A CLICKING NOISE. NO IMPACT TO THE PATIENT'S BLOOD GLUCOSE LEVELS WAS REPORTED. MEDICAL ATTENTION WAS NOT REQUIRED. THE PATIENT WAS REQUESTED TO UPLOAD DATA LOGS FROM THE DEVICE FOR INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22241609 ↗
• MalfunctionMay 27, 2025Application Program Problem: Medication Error; Application Program Problem: Medication Error

  IT WAS REPORTED BY AN INSULET PATIENT THAT THEY ARE UNABLE TO ENTER A DECIMAL POINT WHEN PROGRAMMING A BOLUS IN THE OMNIPOD 5 IOS APP BEING USED ON THEIR IPHONE. THE PATIENT REPORTED THEY ARE ONLY ABLE TO ENTER A BOLUS IN WHOLE NUMBER UNITS. THE COMPLAINT INFORMATION WAS RECEIVED VIA AN AFFILIATE FORM FROM THE IOS APP STORE, AND NO OTHER INFORMATION WAS PROVIDED. IT IS NOT POSSIBLE TO OBTAIN ADDITIONAL INFORMATION, AS THE PATIENT WAS NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087857 ↗
• MalfunctionMay 27, 2025Application Program Problem: Medication Error; Application Program Problem: Medication Error

  IT WAS REPORTED BY THE PATIENT THAT THE BOLUS CALCULATOR IS NOT RECOGNIZING THE DECIMAL ON THEIR OMNIPOD 5 IOS APP. THE PATIENT GAVE AN EXAMPLE THAT IF BOLUS AMOUNT IS PROGRAMMED FOR 1.1 UNITS, THE APP CHANGES IT TO 11 UNITS. THE EVENT OCCURRED DUE TO THE USER SET THE DEVICE'S REGION WITHIN THE PHONE'S SETTINGS (NOT THE OP5 IOS APP) TO SOUTH AFRICA, WHICH UTILIZES A COMMA INSTEAD OF A PERIOD AS THE DECIMAL SEPARATOR CHARACTER FOR NUMBERS. WHEN THE USER TRIES TO PRESS ON THE DECIMAL CHARACTER (COMMA), NOTHING IS ENTERED INTO THE CALCULATOR. NO ADVERSE EVENT OCCURRED AND MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087792 ↗
• MalfunctionMar 21, 2025Application Program Problem: Medication Error; Application Program Problem: Medication Error

  IT WAS REPORTED BY AN INSULET PATIENT THAT THEY ARE UNABLE TO ENTER A DECIMAL POINT IN THE OMNIPOD 5 APP WHEN PROGRAMMING A BOLUS. PATIENT REPORTED THEY ARE ONLY ABLE TO DELIVER A BOLUS IN WHOLE NUMBERS. NO OTHER INFORMATION IS AVAILABLE. COMPLAINT WAS REPORTED VIA AN AFFILIATE FORM, THEREFORE FOLLOW UP FOR ADDITIONAL INFORMATION IS NOT POSSIBLE, AS THE PATIENT IS UNABLE TO BE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665793 ↗