Omnipod 5 Controller APP M009-3P-APRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10385083000565), received between Jun 11, 2025 and Mar 18, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Program or Algorithm Execution Failure

  IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO USE A TEMPORARY BASAL RATE ON THE ANDROID OMNIPOD APPLICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626748 ↗
• InjuryMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE OMNIPOD APP AND DEXCOM CONTINUOUS GLUCOSE MONITOR WERE DISPLAYING CONFLICTING BLOOD GLUCOSE RESULTS. THE PATIENT STATED HE BEGAN FEELING TIRED, CONFUSED, AND BECAME UNCONSCIOUS. HE WOKE UP 2-3 HOURS LATER AND LOOKED AT HIS OMNIPOD APP AND IT DISPLAYED A BLOOD GLUCOSE OF 134 MG/DL WHILE HIS DEXCOM APP SHOWED A BLOOD GLUCOSE OF 355 MG/DL. HE RESTARTED HIS ANDROID PHONE AND THEN THE OMNIPOD APP STILL READ THE BLOOD GLUCOSE AS 134 MG/DL. HE DID A FINGERSTICK BLOOD GLUCOSE, WHICH WAS AROUND 300 MG/DL. HE MANUALLY ENTERED THIS FINGERSTICK BLOOD GLUCOSE READING INTO THE OMNIPOD APP TO RECEIVE INSULIN. THE PATIENT WAS FEELING OK AT THE TIME OF THE REPORT.

  Patient problems: Cognitive Changes; Fatigue; Hyperglycemia; Loss of consciousness

  MAUDE report 24591387 ↗
• MalfunctionDec 11, 2025Failure to Deliver; Failure to Deliver

  THE PATIENT REPORTED THAT THEY WERE ADMINISTERING A BOLUS USING THEIR OMNIPOD 5 APPLICATION ON AN IPHONE, BUT THE APPLICATION STOPPED THE BOLUS BEFORE COMPLETING THE ENTIRE PROGRAMMED AMOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777988 ↗
• InjuryDec 4, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA ON (B)(6) 2025. THE PATIENT'S BLOOD GLUCOSE LEVELS DROPPED TO 23 MG/DL AFTER WEARING THE POD FOR MORE THAN 48 HOURS. THEIR SPOUSE DISCOVERED THE PATIENT UNCONSCIOUS, PROMPTING A CALL TO EMERGENCY MEDICAL SERVICES. THE PATIENT RECEIVED TREATMENT WITH A SALINE SOLUTION AND "SOME KIND OF SOLUTION TO RAISE HER BLOOD SUGAR." ON THE DAY OF THE INCIDENT, THE PATIENT INDICATED THAT INSULIN DELIVERY HAD BEEN PAUSED FOR MOST OF THE TIME, YET THEIR BASAL HISTORY INDICATED THAT MORE THAN TWICE THE USUAL AMOUNT OF INSULIN HAD BEEN ADMINISTERED COMPARED TO OTHER DAYS. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD A VIRUS ON THEIR PHONE, WHICH LED THE PHONE STORE TO DELETE AND REINSTALL THE OMNIPOD 5 APPLICATION WHILE ADDRESSING THE VIRUS ISSUE. THE PATIENT STATED THAT NO SETTINGS WERE CONFIGURED IN THE APPLICATION AFTER IT WAS REINSTALLED. TWO DAYS LATER, ON (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND THE POD WAS DISPOSED OF THERE.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23716376 ↗
• MalfunctionSep 2, 2025Defective Alarm; Incorrect Measurement; Defective Alarm; Incorrect Measurement

  THE PATIENT REPORTED THEIR CONTINUOUS GLUCOSE MONITOR (CGM) INDICATED THEIR GLUCOSE LEVELS WERE BETWEEN 160-180 MG/DL, WHILE THEIR ACTUAL BLOOD GLUCOSE WAS 50 MG/DL. THE OMNIPOD 5 SYSTEM DID NOT PAUSE INSULIN DELIVERY DUE TO INACCURATE CGM READINGS. THE PATIENT ALSO STATED THAT THEY DID NOT RECEIVE A LOW GLUCOSE ALERT FROM THE OMNIPOD 5 SYSTEM UNTIL THEIR GLUCOSE LEVEL DROPPED BELOW 45 MG/DL. CGM MANUFACTURER NOTIFIED OF INACCURATE GLUCOSE READINGS ALLEGATION.

  Patient problems: Hypoglycemia

  MAUDE report 22947632 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT WITH HYPOGLYCEMIA. BLOOD GLUCOSE LEVELS DECLINED TO 40 MG/DL WHILE WEARING A POD. SYMPTOMS REPORTED INCLUDE DIFFICULTY AMBULATING, SWEATING, VISUAL DISTURBANCES AND HEART PALPITATIONS. PATIENT REPORTED HYPOGLYCEMIA HAS BEEN ONGOING ISSUE DESPITE RECENTLY HAVING SETTINGS ADJUSTED PER THEIR PHYSICIAN TO INCREASE TARGET BLOOD GLUCOSE LEVELS. IT WAS ALSO NOTED THE PATIENT HAD RECENTLY DOWNLOADED THE OMNIPOD 5 APP, THEREFORE RESETTING THE ADAPTATIVE BASAL FEATURE. THE PATIENT WAS TREATED WITH GLUCOSE GEL AND INTRAVENOUS FLUIDS WITH DEXTROSE. THE PATIENT REMAINED IN THE HOSPITAL AT TIME OF REPORTING.

  Patient problems: Dyskinesia; Hypoglycemia; Visual Disturbances

  MAUDE report 22929936 ↗
• MalfunctionAug 15, 2025Unintended System Motion; Data Problem; Unintended System Motion; Data Problem

  IT WAS REPORTED THE PATIENT RECEIVED MULTIPLE UNPROGRAMMED BOLUSES FROM THEIR OMNIPOD 5 SYSTEM. THE UNPROGRAMMED BOLUSES WERE REPORTED TO BE FOUND IN THE BOLUS HISTORY, BUT NOT REFLECTED IN THE INSULIN ON BOARD. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819510 ↗
• InjuryJul 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT REPORTED THAT THEY SOUGHT MEDICAL ATTENTION AT THE HOSPITAL ON (B)(6) 2025, DUE TO AN ISSUE WITH THE OMNIPOD APP BEING INCOMPATIBLE WITH THEIR SAMSUNG DEVICE. THIS INCOMPATIBILITY LED TO SYMPTOMS SUCH AS VOMITING, SWEATING, CONSTANT URINATION, AND SLEEPINESS, WHICH RESULTED IN A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS HOSPITALIZED FOR THREE DAYS, DURING WHICH THEY RECEIVED FLUIDS, HAD THEIR POD REMOVED, WERE PLACED ON AN INSULIN DRIP, AND HAD THEIR BLOOD GLUCOSE (BG) LEVELS (OVER 250 MG/DL) MONITORED HOURLY. THEY WERE ALSO PUT ON A DIABETIC DIET. AFTER THE MEDICAL EVENT WAS DOCUMENTED, IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ACCESS TO ANY PREVIOUSLY REGISTERED OMNIPOD 5 CONTROLLERS AND HAD LOST ACCESS TO THE OMNIPOD 5 APP DUE TO THE INCOMPATIBILITY.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Fatigue; Hyperglycemia; Nausea; Urinary Frequency / Polyuria; Vomiting

  MAUDE report 22535201 ↗
• MalfunctionJul 11, 2025Unintended System Motion; Unintended System Motion

  THE PATIENT'S DAUGHTER REPORTED AFTER A SOFTWARE UPDATE ON THE PATIENT'S ANDROID SMARTPHONE, THE OMNIPOD SYSTEM HAS BEEN DELIVERING BOLUSES NOT PROGRAMMED BY THE USER. NO IMPACT ON THE PATIENT'S BLOOD GLUCOSE LEVEL WAS REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION RELATED TO THE ALLEGED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484500 ↗
• InjuryJul 11, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE PATIENT'S HCP (HEALTH CARE PROVIDER) MISTAKENLY MADE CHANGES TO THE PATIENT'S PUMP SETTINGS BASED ON A GLOOKO REPORT OF ANOTHER OMNIPOD PATIENT'S DATA. THIS LED TO THE PATIENT BEING HOSPITALIZED WITH HYPERGLYCEMIA. SYMPTOMS, BLOOD GLUCOSE LEVELS, TREATMENT AND LENGTH OF STAY WERE NOT PROVIDED. THREE DUE DILIGENCE ATTEMPTS WERE MADE WITHOUT RECEIVING ANY NEW INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hyperglycemia

  MAUDE report 22484358 ↗
• MalfunctionJul 1, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT REPORTED THE OMNIPOD SYSTEM CONTINUED TO DELIVER INSULIN AFTER INSULIN DELIVERY WAS PAUSED. NO IMPACT TO THE PATIENT'S BLOOD GLUCOSE LEVELS WAS REPORTED. NO MEDICAL ATTENTION WAS REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375586 ↗
• MalfunctionJun 20, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT REPORTED HIS OMNIPOD SYSTEM IS DELIVERING TOO MUCH INSULIN RESULTING IN HYPOGLYCEMIA (LEVELS UNSPECIFIED). HE REPORTED PAUSING INSULIN DELIVERY, AND THE SYSTEM CONTINUED TO DELIVER INSULIN. THE CUSTOMER FELT INSULIN DELIVERY CONTINUED WHILE HE HAD THE SYSTEM PAUSED BECAUSE HIS IOB (INSULIN ON BOARD) INCREASED AFTER THE SYSTEM WAS PAUSED. NO OTHER DETAILS WERE PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302624 ↗
• MalfunctionJun 19, 2025Unintended System Motion; Unintended System Motion

  THE PATIENT REPORTED THE OMNIPOD SYSTEM DELIVERED AN UNPROGRAMMED BOLUS THAT RESULTED IN HYPOGLYCEMIA. BLOOD GLUCOSE LEVELS DECLINED TO 48 MG/DL WHILE WEARING THE POD. NO SYMPTOMS ASSOCIATED WITH HYPOGLYCEMIA WERE REPORTED. THE PATIENT TREATED HER HYPOGLYCEMIA WITH A SNICKERS BAR. NO MEDICAL ATTENTION RELATED TO THIS EVENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. DUE DILIGENCE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION; HOWEVER, NO NEW INFORMATION WAS RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hypoglycemia

  MAUDE report 22289844 ↗
• InjuryJun 18, 2025Unintended System Motion; Unintended System Motion

  THE PATIENT REPORTED THE OMNIPOD SYSTEM DELIVERED 2 UNPROGRAMMED BOLUSES WITH THE SPAN OF AN HOUR. THE PATIENT WAS AWAKENED BY HER HUSBAND, WITH A BLOOD GLUCOSE LEVEL THAT HAD DECLINED INTO THE 40 MG/DL RANGE WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS IN THE ABDOMEN. THE PATIENT REPORTED TREATING THE HYPOGLYCEMIA WITH A SODA, A SNACK AND GLUCAGON INJECTION. HER BLOOD GLUCOSE TEMPORARILY INCREASED TO 60 MG/DL, THEN DECLINED TO 32 MG/DL. EMS (EMERGENCY MEDICAL SERVICES) WAS CALLED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. THE PATIENT EXPERIENCED SYMPTOMS OF WEAKNESS, SHAKING, SWEATING, CONFUSION AND LOSS OF CONSCIOUSNESS. AT THE HOSPITAL, THE PATIENT WAS TREATED WITH 2 BAGS OF IV (INTRAVENOUS) DEXTROSE. THE PATIENT WAS DISCHARGED AFTER 1 DAY. ADDITIONALLY, THE PATIENT REPORTED DIFFICULTY PAIRING HER POD AND CGM (CONTINUOUS GLUCOSE MONITOR). IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Cognitive Changes; Hypoglycemia

  MAUDE report 22286607 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO HYPERGLYCEMIA, WITH BLOOD GLUCOSE LEVELS REACHED 700 MG/DL. THE INCIDENT OCCURRED WHILE WEARING THE POD ON THE ABDOMEN BETWEEN 4 AND 24 HOURS. THE PATIENT STATED SHE REMOVED THE POD AT HOME PRIOR TO BEING TRANSPORTED TO THE EMERGENCY ROOM. THE PATIENT WAS UNABLE TO ADMINISTER INSULIN BECAUSE THE ASSOCIATED APP WAS NOT FUNCTIONING, AND NO BACKUP METHOD WAS AVAILABLE. IN ADDITION TO HYPERGLYCEMIA, THE PATIENT HAD A HEADACHE AND EMERGENCY SERVICES WERE CALLED. THE PATIENT REQUIRED OXYGEN IN THE AMBULANCE AND WAS TREATED WITH INSULIN. AT THE TIME OF REPORT, THE PATIENT HAD NOT YET BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Headache; Hyperglycemia

  MAUDE report 22204592 ↗
• InjuryJun 11, 2025Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS NOT ABLE TO LOG IN TO THE OMNIPOD 5 APPLICATION ON THEIR PHONE. THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 800 MG/DL, AND THEY LOST CONSCIOUSNESS. THE PATIENT'S SON CALLED AN AMBULANCE, AND THE PATIENT WAS TAKEN THE HOSPITAL. AT THE HOSPITAL, THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN AND CLOSELY MONITORED THEIR MAGNESIUM AND POTASSIUM LEVELS, AND PROVIDED TREATMENT BASED ON THOSE OBSERVATIONS. THE CUSTOMER ALSO INFORMED US THAT THEY GOT OCCUPATIONAL THERAPY (OT) AND PHYSICAL THERAPY (PT) ONCE THEY WERE ABLE TO WALK. THE PATIENT WAS DISCHARGED AFTER 6 DAYS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Loss of consciousness

  MAUDE report 22187087 ↗