Omnipod 5 Controller APP M009-2S-APRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10385083000459), received between Jul 10, 2025 and Mar 17, 2026 — classified as 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (6 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. Sep 11, 2025Open, Classified

   The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

   Z-0132-2026 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Application Program Problem: Medication Error

  IT WAS REPORTED THAT WHILE THE PATIENT AND THEIR DIABETES EDUCATOR, WERE ENTERING SETTINGS ON A NEW PHONE, THE EDUCATOR WAS TRYING TO ENTER A DECIMAL POINT, BUT THE APP WOULD NOT REGISTER IT. THE DIABETES EDUCATOR WAS ADVISED TO DELETE AND REINSTALL THE APP AND CALL BACK IF THE ISSUE DID NOT RESOLVE. NO IMPACT TO BLOOD GLUCOSE LEVELS WERE REPORTED. NO MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621131 ↗
• InjuryFeb 6, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION FOR HYPOGLYCAEMIA AND LOSS OF CONSCIOUSNESS. THE PATIENT'S BLOOD GLUCOSE DECLINED TO 29 MG/DL. IT WAS REPORTED THAT THE PATIENT WAS UNCONSCIOUS, COLD, UNRESPONSIVE AND WAS 'MAKING NOISES WITH HER EYES FLIPPED BACK'. THE PATIENT WAS TREATED WITH INTRAVENOUS GLUCOSE AND WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT HAD UPGRADED TO A NEW IPHONE, THE PATIENT WAS USING THE OMNIPOD APP AS THE CONTROLLER FOR HER PODS AND THEIR BASAL SETTINGS HAD BEEN ENTERED INCORRECTLY.

  Patient problems: Alteration in Body Temperature; Hypoglycemia; Loss of consciousness

  MAUDE report 24276708 ↗
• InjuryFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALISED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2025. THE PATIENT REPORTED THAT HIS SENSOR READINGS (DEXCOM G7) WERE SHOWING HIS BLOOD GLUCOSE LEVELS (BGS) TO BE 66 MG/DL HOWEVER A MANUAL TEST SHOWED THAT THE PATIENT¿S BGS ACTUALLY REACHED 500 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTED FEELING CHEST PAIN THAT HE THOUGHT WAS INDIGESTION, WHEN THE PAIN DID NOT SUBSIDE HE PRESENTED AT THE HOSPITAL WHERE HE WAS ADMITTED AND RECEIVED THE DIAGNOSIS OF DKA. THE PATIENT WAS TREATED WITH FLUIDS AND INSULIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. DEXCOM WAS INFORMED ON (B)(6) 2026.

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

  MAUDE report 24256607 ↗
• MalfunctionDec 19, 2025Failure to Deliver; Failure to Deliver

  A REPORTED WAS RECEIVED FROM GLOOKO NOTING A BOLUS ALLEGEDLY DELIVERED BY THE PATIENT WAS NOT REFLECTED ON THE GLOOKO REPORT. IT WAS FELT THE DEVICE MAY NOT HAVE DELIVERED THE PROGRAMMED BOLUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849628 ↗
• InjuryDec 15, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE BASAL SETTINGS FOR THE PATIENT IN THE OMNIPOD 5 APPLICATION ON THE IPHONE WERE ALTERED TO DELIVER 360 UNITS DAILY. THE INCORRECT BASAL SETTING WAS IDENTIFIED AFTER THE PATIENT TRANSITIONED FROM THE OMNIPOD 5 CONTROLLER TO THE OMNIPOD 5 APPLICATION. BLOOD GLUCOSE LEVELS DROPPED TO 40 MG/DL, CAUSING THE PATIENT TO EXPERIENCE SHAKING. THE POD WAS REMOVED, AND THE PATIENT DRANK ORANGE JUICE BEFORE BEING TAKEN TO THE EMERGENCY ROOM. UPON ARRIVAL AT THE EMERGENCY ROOM, THE PATIENT RECEIVED GLUCOSE AND WAS MONITORED CONTINUOUSLY. THE PATIENT WAS DISCHARGED 3 HOURS LATER.

  Patient problems: Hypoglycemia

  MAUDE report 23802464 ↗
• InjuryDec 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD ATTENDED THE EMERGENCY DEPARTMENT WITH HYPERGLYCAEMIA ON (B)(6) 2025. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 700 MG/DL WHILE WEARING A POD. THE PATIENT REPORTED THAT THEIR PHONE HAD CRASHED AND BECOME NON-FUNCTIONAL, WHICH INCLUDED LOSS OF ACCESS TO THE OMNIPOD APPLICATION. THE PATIENT DID NOT HAVE A BACKUP METHOD FOR INSULIN DELIVERY. SYMPTOMS REPORTED INCLUDE PALLOR, VOMITING, WEAKNESS AND FEELING GENERALLY UNWELL. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN. THE POD WAS REMOVED AT THE HOSPITAL AND DISCARDED. THE PATIENT WAS RELEASED LATER THE SAME DAY.

  Patient problems: Hyperglycemia; Pallor; Vomiting

  MAUDE report 23801079 ↗
• InjuryDec 12, 2025Communication or Transmission Problem; Reset Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE PATIENT REMOVED A POD AND REINSTALLED THE OMNIPOD 5 APPLICATION FOLLOWING A "POD IS NO LONGER CONNECTED TO APP, REMOVE APP AND REINSTALL" ALERT ON THE APP. AROUND THE SAME TIME, THE PATIENT RECEIVED A MAXIMUM STORAGE ALERT ON HIS IPHONE. FOLLOWING THE APP REINSTALLATION, THE PATIENT'S SETTING ON THE APP WAS ERASED AND THE PATIENT WAS UNABLE TO RESUME TREATMENT. THE PATIENT HAD NO BACKUP INSULIN AVAILABLE AT THAT TIME. CONSEQUENTLY, THE PATIENT EXPERIENCED HYPERGLYCEMIA AND WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS ON (B)(6) 2025. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, BURNING SENSATION, CHEMICAL TASTE IN THE MOUTH, NAUSEA, VOMITING, DYSPNEA, AND SWEATING. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN AND FLUIDS. THE PATIENT WAS RELEASED THE FOLLOWING DAY (B)(6) 2025F.

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

  MAUDE report 23787407 ↗
• InjuryDec 3, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALISED WITH HYPOGLYCAEMIA ON (B)(6) 2025. THEY REPORTED THAT THEY HAD NOT BEEN COUNTING THEIR CARBOHYDRATES ACCURATELY. THE GLUCOSE LEVEL DECLINED TO APPROXIMATELY 20 MG/DL. SYMPTOMS REPORTED INCLUDE LOSS OF CONSCIOUSNESS AND SEIZURES. THE PATIENT DID NOT RECALL WHAT TREATMENT THEY RECEIVED OTHER THAN HAVING A CT SCAN AND ELECTROCARDIOGRAM. THE PATIENT WAS RELEASED AFTER TWO DAYS. THE POD WAS DISCARDED.

  Patient problems: Convulsion/Seizure; Hypoglycemia; Loss of consciousness

  MAUDE report 23705679 ↗
• InjuryNov 24, 2025Excess Flow or Over-Infusion; Unintended System Motion; Excess Flow or Over-Infusion; Unintended System Motion

  THE PATIENT REPORTED THAT THEY EXPERIENCED AN UNREQUESTED BOLUS OF 2.85 UNITS ON (B)(6) 2025 DURING THEIR SLEEP. THEIR BLOOD GLUCOSE LEVEL FELL TO 30 MG/DL, RESULTING IN A LOSS OF CONSCIOUSNESS. EMERGENCY MEDICAL SERVICES WERE CONTACTED, AND THEY ADMINISTERED ORAL GLUCOSE ALONG WITH A SANDWICH TO THE PATIENT. SUBSEQUENTLY, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE THEY RECEIVED ADDITIONAL TREATMENT WITH ORAL GLUCOSE.

  Patient problems: Hypoglycemia

  MAUDE report 23631585 ↗
• MalfunctionNov 21, 2025Failure to Analyze Signal; Failure to Analyze Signal

  THE PATIENT REPORTED THAT THEY ACCIDENTALLY PROGRAMMED A BOLUS OF 4 UNITS INSTEAD OF THE INTENDED 0.4 UNITS. UPON QUICKLY REALIZING THE MISTAKE, THE PATIENT TRIED TO CANCEL THE BOLUS. HOWEVER, THE PATIENT REPORTED THAT THE BOLUS COULD NOT BE CANCELED. NO IMPACT ON THE PATIENT'S GLUCOSE LEVELS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617269 ↗
• MalfunctionNov 20, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT REPORTED THAT THEY EXPERIENCED AN UNREQUESTED BOLUS AT THE SAME TIME AS A SCHEDULED BOLUS FROM THEIR OMNIPOD 5 APPLICATION. THERE WAS NO REPORTED IMPACT ON THE PATIENT'S BLOOD GLUCOSE LEVELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606816 ↗
• InjuryNov 19, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PARTNER COMPLAINT FROM DEXCOM REPORTED THAT THE PATIENT INADVERTENTLY ADMINISTERED A BOLUS OF 41 UNITS OF INSULIN, LEADING TO HYPOGLYCEMIA. THE PATIENT CONSUMED FOOD AND BELIEVED THEIR BLOOD GLUCOSE LEVELS WERE INCREASING. THE PATIENT WAS SUBSEQUENTLY DISCOVERED UNCONSCIOUS, PROMPTING A CALL TO EMERGENCY MEDICAL SERVICES. AT THE TIME OF THIS REPORT, THE PATIENT WAS IN A COMA.

  Patient problems: Coma; Hypoglycemia

  MAUDE report 23599831 ↗
• MalfunctionNov 17, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT'S PARENT REPORTED THAT THEIR OMNIPOD 5 PERSONAL DIABETES MANAGER ADMINISTERED AN UNREQUESTED BOLUS. NO ADDITIONAL DETAILS WERE PROVIDED. FURTHER INFORMATION WAS REQUESTED BUT NOT OBTAINED. SHOULD ANY FURTHER INFORMATION BE RECEIVED, A SUPPLEMENTARY REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575397 ↗
• InjuryOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON B)(6) 2025. IT WAS REPORTED THAT THE PATIENT RECENTLY UPGRADED HER PHONE TO AN IPHONE 17 WHICH IS CURRENTLY NOT COMPATIBLE WITH THE OMNIPOD 5 SYSTEM. ACCORDING TO THE REPORTER, THE PATIENT WAS RELEASED AFTER A FEW HOURS. MULTIPLE ATTEMPTS WERE MADE TO GAIN MORE INFORMATION BUT THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE SYMPTOMS EXPERIENCED AND TREATMENT THAT WAS PROVIDED.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 23415152 ↗
• InjuryOct 24, 2025Loss of Data; Loss of Data

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT EXPERIENCED TROUBLE CONNECTING TO THE PHONE DUE TO STORAGE ISSUE. THE SYSTEM WAS IN MANUAL MODE PRIOR TO DKA. TREATMENT, BLOOD GLUCOSE LEVEL, TIME POD WAS WORN, SYMPTOMS, AND LENGTH OF HOSPITAL ADMISSION WERE NOT REPORTED. THREE ATTEMPTS WERE MADE TO FOLLOW UP BUT THEY WERE UNSUCCESSFUL THEREFORE INFORMATION IS LIMITED.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 23381024 ↗
• InjurySep 19, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE PATIENT RECEIVED MORE INSULIN THAN EXPECTED FROM THEIR OMNIPOD 5 SYSTEM, WHICH LED TO HYPOGLYCEMIA, LOSS OF CONSCIOUSNESS, REQUIRED EMERGENCY MEDICAL SERVICES (EMS) AND A SUBSEQUENT VISIT TO THE EMERGENCY ROOM. THE PATIENT'S FATHER CALLED EMS AFTER RECEIVING A LOW GLUCOSE ALERT AND DISCOVERING THAT THE PATIENT WAS UNCONSCIOUS. THE PATIENT WAS TREATED BY EMS WITH A GLUCAGON INJECTION AND LATER TRANSPORTED TO THE EMERGENCY ROOM BY THEIR FATHER. THE FATHER MENTIONED THAT A NEW POD HAD BEEN PLACED THE NIGHT BEFORE, FILLED WITH 200 UNITS OF INSULIN. AT THE TIME OF THE HYPOGLYCEMIC EVENT, THE CONTROLLER INDICATED THAT ONLY 10 UNITS OF INSULIN WERE LEFT. THE PUMP WAS OPERATING IN MANUAL MODE, AND UPON ARRIVAL AT THE EMERGENCY ROOM, IT WAS DISCOVERED THE BASAL RATE WAS INCORRECTLY SET TO DELIVER 8 UNITS PER HOUR INSTEAD OF THE CORRECT 0.8 UNITS PER HOUR.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23102649 ↗
• InjurySep 19, 2025Excess Flow or Over-Infusion; Unintended System Motion; Excess Flow or Over-Infusion; Unintended System Motion

  IT WAS REPORTED THE PATIENT RECEIVED 2 UNPROGRAMMED BOLUSES OF 20 UNITS EACH, THAT RESULTED IN HYPOGLYCEMIA AND HOSPITALIZATION.

  Patient problems: Hypoglycemia

  MAUDE report 23100958 ↗
• InjuryAug 8, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN UNPROGRAMMED BOLUS. THE PATIENT'S MOTHER REPORTED HEARING THE POD BEEPING, AND THE OMNIPOD 5 APP SHOWED THE POD WAS EMPTY. IT WAS REPORTED THE POD HAD BEEN FILLED WITH 200 UNITS OF INSULIN 3.5 TO 4 HOURS PRIOR TO THE EVENT. EMERGENCY MEDICAL SERVICES WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED WITH JUICE. THE PATIENT WAS DISCHARGED FROM THE ER AFTER 4 HOURS. THE BLOOD GLUCOSE LEVEL WAS WERE REPORTED TO BE 300 MG/DL AFTER TREATMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754170 ↗
• MalfunctionJul 30, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE UNPROGRAMMED BOLUSES FROM THEIR OMNIPOD 5 SYSTEM RESULTING IN HYPOGLYCEMIA. BLOOD GLUCOSE LEVELS DECLINED INTO THE LOWER 50 MG/DL RANGE. NO MEDICAL TREATMENT WAS REQUIRED FOR THE REPORTED ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hypoglycemia

  MAUDE report 22668009 ↗
• InjuryJul 10, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT REPORTED A MEDICAL EVENT RELATED TO AN OVER DELIVERY OF INSULIN. BLOOD GLUCOSE LEVELS DECLINED TO 40 MG/DL WHILE WEARING THE POD RESULTING IN TREATMENT BY EMS (EMERGENCY MANAGEMENT SERVICES) WITH IV (INTRAVENOUS) DEXTROSE. THE POD WAS REMOVED AT THE HOSPITAL AND NO FURTHER TREATMENT WAS PROVIDED AS THE PATIENT'S BLOOD GLUCOSE LEVELS STARTED TO STABILIZE.

  Patient problems: Hypoglycemia

  MAUDE report 22472427 ↗