Omnipod 5 Controller APP 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10385081120302), received between Oct 12, 2022 and Jun 26, 2026 — classified as 25 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation 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. Feb 28, 2023Open, Classified

   An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an email was sent to all phone control users and the cause of the error message was resolved by reverting to prior certificates on the Insulet cloud to secure communications between the Omnipod 5 App sotware and the Insulet Cloud. This issue was limited to only certain compatible Android smartphones and did not affect the Omnipod 5 Pods or the dedicated locked-down Controller provided by Insulet. All other Omnipod 5 users were still able to manage their insulin with the device without use of the smartphone app and affected users were able to switch to the locked-down control provided to all users when they initiated the device during the time the App was unavailable to them. Further, the Omnipod itself continued to deliver insulin as per its pre-programmed settings so although affected users who did not have the locked-down controller readily available may not have been able to command insulin boluses during this time, they continued to receive basal insulin without interruption. Lastly, users of the Omnipod 5 were advised during training to always have backup supplies ready in the event of a device malfunction which would include alternative means to deliver insulin subcutaneously until the issue is resolved to minimize disruption to their insulin regimen. There were 2,168 complaints received out of 7,838 users with the Android compatible smartphones affected and 9 MDRs were submitted, however, there were no serious injuries reported or reports of erroneous results as the primary issue was a delay in therapy. This defect cannot cause false results that could negatively impact patients.

   Z-2618-2023 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT¿S OMNIPOD SYSTEM WAS NOT ADMINISTERING BOLUS INSULIN. THE PATIENT CONTACTED INSULET CUSTOMER SUPPORT REGARDING A RECURRING ISSUE WITH HER INSULIN POD WHERE, EVERY NIGHT BETWEEN 6:00 PM AND 8:30 PM, HER BLOOD GLUCOSE LEVELS CLIMB TO 180 AND THEN PLATEAU BETWEEN 230-250 MG/DL. DESPITE THE SYSTEM CALCULATING CORRECTION DOSES CORRECTLY, IT ONLY DISPLAYS THE CORRECTION INSULIN AS "INSULIN ON BOARD" WITHOUT ACTUALLY ADMINISTERING INSULIN. THE INSULIN IS ONLY DELIVERED WHEN SHE ENTERS CARBOHYDRATE INTAKE, EVEN IF SHE HASN'T EATEN. THE PATIENT WAS INSTRUCTED TO REVIEW SETTINGS WITH THEIR HEALTHCARE PROVIDER, TO ENSURE SETTINGS ARE SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637801 ↗
• MalfunctionJun 26, 2026Failure to Deliver

  THE PATIENT REPORTED THAT THE SYSTEM WAS NOT DELIVERING BOLUS INSULIN, AFTER WEARING THE POD FOR APPROXIMATELY TWO DAYS. BLOOD GLUCOSE LEVELS WERE NOT PROVIDED, BUT PATIENT NOTED THAT THEY "WENT HIGH" AS A RESULT OF THIS EVENT. MEDICAL TREATMENT WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633766 ↗
• MalfunctionJun 16, 2026Failure to Deliver; Connection Problem

  THE PATIENT REPORTED THAT MULTIPLE BOLUS ATTEMPTS WERE MADE, BUT THE SYSTEM WAS UNABLE TO CONFIRM DELIVERY, RESULTING IN AN ¿UNCONFIRMED¿ STATUS FOR THE LAST BOLUS. AT THE TIME OF POD DEACTIVATION, THE SYSTEM INDICATED IT WAS UNABLE TO CONFIRM HOW MUCH OF THE LAST BOLUS WAS DELIVERED, AND THAT THE RECORDED VALUE REFLECTED THE AMOUNT THAT HAD BEEN SCHEDULED FOR DELIVERY. CUSTOMER CONFIRMED THAT THE SYSTEM PROMPTED DEACTIVATION OF THE POD AFTER UNSUCCESSFUL ATTEMPTS TO COMPLETE INSULIN DELIVERY. PATIENT REPORTED COMMUNICATION ISSUES BETWEEN THE POD AND THEIR CONTROLLER. BLOOD GLUCOSE LEVELS WERE NOT REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25517588 ↗
• MalfunctionJun 9, 2026Unintended System Motion

  IT WAS REPORTED THAT WHILE SKYDIVING, AND WITH THEIR OMNIPOD SYSTEM IN ACTIVITY MODE; THE SYSTEM DELIVERED AN UNCOMMANDED BOLUS OF APPROXIMATELY 6-8 UNITS OF INSULIN DURING AN UNPRESSURIZED FLIGHT TO 14,000 FEET. THE PATIENT'S BLOOD GLUCOSE LEVEL DECREASED TO 34 MG/DL. AS TREATMENT THE PATIENT CONSUMED 200 GRAMS OF CARBOHYDRATES, OVER TWO HOURS, TO STABILIZE THEIR BLOOD GLUCOSE LEVELS. MEDICAL TREATMENT WAS NOT REQUIRED.

  Patient problems: Hypoglycemia

  MAUDE report 25442895 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  PATIENT REPORTED THAT A POD WAS NOT BEING WORN AT THE TIME MEDICAL ATTENTION WAS SOUGHT, AS THE POD HAD COME OFF DURING SLEEP. THE PATIENT REPORTED EXPERIENCING NAUSEA AND ELEVATED GLUCOSE VALUES. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE DIABETIC KETOACIDOSIS WAS DIAGNOSED. INSULIN THERAPY WAS ADMINISTERED AND THE PATIENT WAS HOSPITALIZED FOR THREE DAYS AND BEING DISCHARGED ON (B)(6) 2026. PATIENT STATED THAT THE EVENT WAS NOT RELATED TO RECEIVING INSULIN AFTER THE POD CAME OFF AND THAT THE SYSTEM RECORDS INDICATED THAT THE POD RESERVOIR WAS EMPTY ON (B)(6) 2026. IT IS UNKNOWN WHETHER ANY CONTROLLER MESSAGE WAS DISPLAYED, AS THIS INFORMATION WAS NOT REPORTED. BLOOD GLUCOSE VALUES AT THE TIME OF THE EVENT WERE NOT AVAILABLE, AS THE PATIENT WAS UNABLE TO RECALL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Nausea

  MAUDE report 25331823 ↗
• InjuryMay 6, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED GREATER THAN 250 MG/DL WHILE WEARING THE POD. THE POD CONTROLLER GENERATED AN "OMNIPOD 5 APP ERROR" ERROR MESSAGE. THE PATIENT SELECTED ¿OK¿ TO CONTINUE; HOWEVER, THE SYSTEM REMAINED STUCK AT 8% ON THE OMNIPOD 5 LOADING BAR AFTER REBOOTING. THEY ALSO ATTEMPTED TO RESTART THE APP, BUT IT CONTINUED TO FREEZE AT 8%. FURTHERMORE, THEY HAVE BEEN UNABLE TO ADMINISTER INSULIN OR CONTROL THE OMNIPOD SINCE 2:00 PM, SUBSEQUENTLY GOING TO THE HOSPITAL DUE TO FEELING UNWELL. SYMPTOMS REPORTED INCLUDE VOMITING, FEELING AGITATED, DIFFICULTY BREATHING, AND EXPERIENCING CONFUSION. THE PATIENT WAS TREATED WITH ZOFRAN FOR NAUSEA, TWO UNSPECIFIED INTRAVENOUS FLUID BAGS TO HELP STABILIZE THEIR CONDITION AND INSULIN TO HELP LOWER THEIR GLUCOSE LEVELS. THE PATIENT WAS STILL ADMITTED AT THE TIME OF THIS REPORT.

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

  MAUDE report 25107755 ↗
• MalfunctionApr 15, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PATIENTS' BLOOD GLUCOSE LEVEL DECREASED TO 38 MD/DL AND BELIEVES IT WAS DUE TO A TECHNICAL ISSUE RELATED TO THE AUTOMATED SYSTEM. THE PATIENT REPORTED THAT THEY CALLED THEIR NURSE AND DOCTOR'S OFFICE AND WAS ADVISED TO GO TO THE ER, BUT HE DID NOT GO. THE PATIENT TREATED HIS LOW GLUCOSE LEVEL WITH GLUCOSE TABLETS, SUGAR, JUICE, COFFEE AND FOOD. PATIENT REPORTED THAT THEY DO NOT TRUST AUTOMATED SYSTEMS ANYMORE AND REQUESTED HIS DOCTOR TO UPDATE HIS PRESCRIPTION TO GO BACK TO MANUAL INSULIN INJECTIONS.

  Patient problems: Hypoglycemia

  MAUDE report 24885273 ↗
• MalfunctionApr 9, 2026Failure to Deliver; Application Program Problem

  IT WAS REPORTED THAT THE PATIENT CHANGED THE POD AND IT DID NOT CONNECT WITH THE SENSOR. ADDITIONALLY, THE SMARTBOLUS CALCULATOR OPTION WAS GRAYED OUT. BLOOD GLUCOSE LEVELS WERE REPORTED TO BE 356 MG/DL. NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: Hyperglycemia

  MAUDE report 24829076 ↗
• MalfunctionApr 6, 2026Application Program Problem: Medication Error

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THE APP. THE PATIENT COULD NOT DEACTIVATE THE POD OR GIVE THEMSELF A BOLUS. WHEN TRYING TO USE THE BOLUS CALCULATOR, THE PATIENT WOULD INPUT VALUES BUT IT WAS GIVING THEM AN INCORRECT AMOUNT OF UNITS. IMPACT TO PATIENT'S BLOOD GLUCOSE WAS NOT REPORTED. MEDICAL ASSISTANCE WAS NOT REQUIRED, AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789181 ↗
• InjuryMar 26, 2026Use of Device Problem; Computer System Security Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS DECLINED TO BELOW 54 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE LOSS OF CONSCIOUSNESS. THE PATIENT HAD CALLED INSULET ON (B)(6) 2026 AT 00:59 AM STATING THAT SHE DELETED THE PHONE OMNIPOD APPLICATION (APP) ON HER PHONE AND NEEDED ASSISTANCE AND THEN CALLED BACK IN ON (B)(6) 2026 AT 09:34 STATING THAT SHE ACCIDENTALLY DELETED HER OMNIPOD 5 APP WHILE TRYING TO FREE UP SPACE ON HER ANDROID PHONE. THE CUSTOMER DID NOT HAVE HER OMNIPOD 5 SETTINGS, AND THE AGENT DIRECTED THE CUSTOMER TO CALL HER HEALTH CARE PROVIDER FOR HER SETTINGS AND THEN TO CALL INSULET BACK IF SHE NEEDED FURTHER ASSISTANCE IN UPLOADING AND PROGRAMMING HER OMNIPOD 5 APP. THE PATIENT CALLED BACK IN ON (B)(6) 2026 AT 13:08 FOR ASSISTANCE IN RESETTING HER INSULET PASSWORD AND FOR ASSISTANCE IN UPLOADING HER OMNIPOD 5 APP. THE PATIENT STATED THAT SHE ONLY REMEMBERS BITS AND PIECES ABOUT WHAT HAPPENED. THE CUSTOMER IS NOT SURE IF SHE PROGRAMMED HER NEW APP OR WHAT TRANSPIRED AFTER SHE SPOKE TO INSULET ON (B)(6) 2026. ACCORDING TO THE PATIENT¿S HEALTH CARE PROVIDER,

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 24701489 ↗
• MalfunctionMar 11, 2026Unintended System Motion

  IT WAS REPORTED THAT THE PATIENT NOTICED SEVERAL UNCOMMANDED BOLUSES AFTER A SOFTWARE UPDATE ON THEIR ANDROID PHONE. THE UPDATE WAS DONE ON (B)(6) 2026 AND THEY EXPERIENCED UNCOMMANDED BOLUSES ON (B)(6) 2026, (B)(6) 2026, AND (B)(6) 2026. THE PHONE HAD BEEN LOCATED IN THE BACKPACK OF THE PATIENT IN THE SCHOOL NURSE'S OFFICE AND THE PATIENT WAS IN PHYSICAL EDUCATION CLASS. THE UNEXPECTED BOLUSES REPORTED THAT OCCURRED ON (B)(6) 2026 WERE AS FOLLOWS: 09:18 = 5 UNITS; 09:39 = 5 UNITS; 09:54 = 5 UNITS; 10:09 = 2 UNITS; 10:31 = 2 UNITS; 10:38 = 3 UNITS; 13:36 = 1 UNIT. THE PATIENT¿S BLOOD GLUCOSE WAS REPORTED TO HAVE BEEN LESS THAN 54 MG/DL, BUT EXACT RESULTS AND ANY TREATMENT PROVIDED WERE NOT SPECIFIED. THE (B)(6) 2026 EVENT IS REPORTED IN INSULET REFERENCE NUMBER (B)(4) AND THE (B)(6) 2026 EVENT IS REPORTED IN INSULET REFERENCE NUMBER (B)(4).

  Patient problems: Hypoglycemia

  MAUDE report 24570954 ↗
• MalfunctionMar 6, 2026Application Program Problem: Dose Calculation Error

  IT WAS REPORTED BY THE PATIENT THAT THE APP HAD TROUBLE CONNECTING TO THE POD AND THAT AN UNCOMMANDED BOLUS OF 12.1 UNITS HAD BEEN ADMINISTERED. THEIR INSULIN ON BOARD AT THE TIME WAS REPORTEDLY 6.75 UNITS. THE PATIENT REPORTED THEY WERE CONCERNED THAT THEIR BLOOD GLUCOSE LEVEL WOULD DECREASE, DUE TO THE BOLUS HE DID NOT COMMAND, BECAUSE THEIR MAXIMUM BOLUS AMOUNT IS 5 UNITS. THE PATIENT REPORTED THAT THEIR BLOOD GLUCOSE LEVELS WERE HOLDING STEADY AT AROUND 140 MG/DL THE ENTIRE DAY. PATIENT STATED THEY WOULD MONITOR THEIR BLOOD GLUCOSE LEVELS AND TREAT HYPOGLYCEMIA, WITH SUGAR AND BASQSIMI NASAL SPRAY (GLUCAGON), IF NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535237 ↗
• InjuryMar 2, 2026Problem with Software Installation

  IT WAS REPORTED THAT THE PATIENT WAS TRANSPORTED BY THE EMERGENCY MEDICAL SERVICES (EMS) TO THE EMERGENCY ROOM WITH HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS DECLINED TO AROUND 20 MG/DL WHILE WEARING THE POD FOR AN UNKNOWN DURATION. THE PATIENT TRIED DELETING AND REINSTALLING THE POD'S APPLICATION SINCE THEY WERE HAVING TROUBLE ACTIVATING A NEW POD. THEY WERE NOT ABLE TO LOGIN TO THEIR ACCOUNT, LEADING THEM TO SWITCH TO MANUAL INSULIN INJECTIONS BUT RESULTED THEM INTO HAVING BLOOD GLUCOSE LEVEL TO DECLINE. THE PATIENT WAS TREATED WITH NASAL GLUCAGON AND DEXTROSE. THE PATIENT WAS DISCHARGED ON THE SAME DAY. THE PATIENT REMOVED THE POD PRIOR TO THE EMERGENCY ROOM VISIT.

  Patient problems: Hypoglycemia

  MAUDE report 24490377 ↗
• InjuryFeb 27, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION ON (B)(6) 2026, DUE TO HIGH BLOOD GLUCOSE LEVELS AND HEADACHES. NO SPECIFIC BLOOD GLUCOSE LEVELS WERE PROVIDED. THE PATIENT STATED SHE WAS DIAGNOSED WITH A HYPERGLYCEMIC EPISODE AND WAS TREATED USING AN INSULIN SLIDING SCALE. SHE REMAINED IN THE MEDICAL FACILITY FOR APPROXIMATELY FOUR HOURS AND RETURNED HOME THE SAME DAY. PRIOR TO SEEKING MEDICAL ATTENTION, THE PATIENT REPORTED THAT SHE WAS UNABLE TO CONNECT HER DEXCOM G6 CONTINUOUS GLUCOSE MONITOR TRANSMITTER SERIAL NUMBER IN THE OMNIPOD IPHONE APPLICATION. NO FURTHER INFORMATION WAS PROVIDED DESPITE GOOD-FAITH EFFORTS TO GATHER ADDITIONAL DETAILS.

  Patient problems: Headache; Hyperglycemia

  MAUDE report 24469239 ↗
• InjuryFeb 11, 2026Application Program Problem

  THE PATIENT¿S FATHER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2026, DUE TO CONCERNS RELATED TO ELEVATED BLOOD GLUCOSE (BG) LEVELS AND KETONES. NO SPECIFIC BG LEVELS WERE REPORTED. THE FATHER STATED THAT WHILE THE PATIENT ATTEMPTED TO CHANGE THE POD, AN APPLICATION ERROR OCCURRED. DUE TO THE APPLICATION ERROR, THE PATIENT WAS UNABLE TO NAVIGATE WITHIN THE APP AND WAS UNABLE TO SUCCESSFULLY REPLACE THE POD. THE FATHER REPORTED THAT THE PATIENT¿S KETONE LEVEL WAS 2.8, AND BLOOD GLUCOSE LEVELS WERE ELEVATED. NO ADDITIONAL SYMPTOMS WERE REPORTED. TROUBLESHOOTING WAS PERFORMED WITH INSULET PRODUCT SUPPORT; HOWEVER, THE ERROR DID NOT CLEAR. DUE TO THE LACK OF A BACKUP INSULIN DELIVERY METHOD AND THE UNRESOLVED APPLICATION ERROR, THE PATIENT PRESENTED TO THE HOSPITAL FOR EVALUATION AND TREATMENT. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN AND WAS DISCHARGED THE SAME DAY AFTER A FEW HOURS.

  Patient problems: Hyperglycemia

  MAUDE report 24316946 ↗
• InjuryFeb 10, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED BY STAFF AT (B)(6), THAT THE PATIENT¿S FAMILY INDEPENDENTLY TRANSITIONED THE OMNIPOD SYSTEM FROM USE WITH THE CONTROLLER TO USE WITH THE IPHONE APPLICATION. DURING THIS TRANSITION, THE PATIENT¿S MOTHER REPORTEDLY ENTERED A BASAL RATE OF 12 UNITS PER HOUR INSTEAD OF THE INTENDED 1.2 UNITS PER HOUR, AND THE MAXIMUM BASAL LIMIT WAS ALSO SET TO 12 UNITS PER HOUR. OVER THE WEEKEND FOLLOWING THESE CHANGES, THE PATIENT EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT, DURING WHICH BAQSIMI (GLUCAGON NASAL POWDER) WAS ADMINISTERED. NO ADDITIONAL DETAILS REGARDING BLOOD GLUCOSE VALUES, LENGTH OF HOSPITALIZATION, OR DISCHARGE DATE WERE AVAILABLE AFTER MULTIPLE GOOD-FAITH EFFORTS FOR FURTHER INFORMATION. BASED ON THE AVAILABLE INFORMATION, THE EVENT APPEARS TO BE ASSOCIATED WITH AN INCORRECT BASAL RATE ENTERED BY THE USER DURING SETUP OF THE IPHONE APPLICATION.

  Patient problems: Hypoglycemia

  MAUDE report 24304289 ↗
• InjuryFeb 10, 2026Use of Device Problem

  THE PATIENT'S HEALTH CARE PROVIDER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS DUE TO THE OMNIPOD SYSTEM SWITCHING INTO MANUAL MODE. THE DATE OF ADMISSION AND MEDICAL TREATMENT WERE NOT PROVIDED, AND THERE WERE NO ADDITIONAL DETAILS REGARDING THIS EVENT DESPITE MULTIPLE GOOD-FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 24304251 ↗
• InjuryJan 6, 2026Inaccurate Delivery

  ACCORDING TO THE REPORTER, THE PATIENT VISITED THE EMERGENCY ROOM ON (B)(6) 2025. THE PATIENT'S BLOOD GLUCOSE LEVELS DECREASED TO LESS THAN 54 MG/DL. THE PATIENT REPORTED NEEDING TO REMOVE THE POD DUE TO A MEMORY CORRUPTION ERROR ON THE OMNIPOD 5 IPHONE APP. THE PATIENT THEN RELIED ON BACKUP TREATMENT AND DID NOT RESUME TREATMENT ON THE PODS. THE PATIENT WAS IN THE ER AT THE TIME OF THE COMPLAINT. AT THIS TIME THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF INSULET'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN SOLICITED, AND A SUPPLEMENTARY REPORT WILL BE FILED IF RECEIVED.

  Patient problems: Hypoglycemia

  MAUDE report 23979688 ↗
• InjurySep 19, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PATIENT HAD BEEN ADMITTED TO THE EMERGENCY ROOM WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD. THE PATIENT HAD TO REMOVE THE POD BECAUSE IT NO LONGER DELIVERED INSULIN AFTER THE OMNIPOD 5 APPLICATION CRASHED AND WOULD NOT RESPOND. SYMPTOMS REPORTED INCLUDE A STOMACH ACHE, DRY MOUTH AND KETONES WERE PRESENT. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS. THE PATIENT WAS RELEASED AFTER 3 HOURS.

  Patient problems: Dry Mouth; Hyperglycemia; Pain

  MAUDE report 23102094 ↗
• InjuryJun 4, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED THAT ON (B)(6) 2025, SHE WAS TAKEN TO THE HOSPITAL BY AMBULANCE BECAUSE SHE EXPERIENCED HYPOGLYCEMIA THAT DROPPED TO LESS THAN 54 MG/DL WHILE USING HER CONTROLLER IN MANUAL MODE, WHICH CONTINUED TO PUMP INSULIN DESPITE HER DROPPING BLOOD GLUCOSE LEVELS. THE OMNIPOD SYSTEM HAS TO BE IN AUTOMATED MODE IN ORDER TO PAUSE INSULIN DELIVERY IF THE CGM (CONTINUOUS GLUCOSE MONITOR) IS RELAYING READINGS OF 55 MG/DL OR LESS. THE PATIENT REPORTED HER HYPOGLYCEMIA RESULTED IN HER LOSING THE ABILITY TO SPEAK FOR 7 HOURS. SHE CALLED AN AMBULANCE AND WAS TAKEN TO THE HOSPITAL. THE PATIENT STATED THAT SHE WAS UNABLE TO LOG INTO HER CONTROLLER, PROMPTING HER TO SWITCH TO AN IPHONE (WHICH IS NOT COMPATIBLE WITH HER G7 PODS) AND STAY IN MANUAL MODE, WHICH SHE BELIEVES CAUSED HER HOSPITALIZATION. SHE WAS AWARE THAT IN MANUAL MODE THE PUMP HAS TO BE PAUSED BY THE USER BUT STATED SHE HAD ALWAYS RELIED ON THE CLOSED-LOOP SYSTEM IN AUTOMATED MODE. HER BLOOD GLUCOSE LEVEL WAS RECORDED AS LOW, AND SHE TREATED IT BY CALLING AN AMBULANCE. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM.

  Patient problems: Hypoglycemia; Speech Disorder

  MAUDE report 22145127 ↗
• MalfunctionJun 2, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED AN UNCOMMANDED BOLUS OF 14.5 UNITS OF INSULIN ON (B)(6) 2025. AFTER REVIEWING THE BOLUS HISTORY, THE PATIENT REPORTED THE UNCOMMANDED BOLUS WAS ACTUALLY FOR 20 UNITS, HOWEVER HIS POD RAN OUT OF INSULIN AND WAS ONLY ABLE TO DELIVER 14.5 UNITS. THE BOLUS HISTORY SHOWED BOLUS CALCULATION FOR 0 CARBOHYDRATES, AND NO BLOOD GLUCOSE LEVEL. PRIOR IOB (INSULIN ON BOARD) SHOWED 1.65 UNITS, BUT NO ADJUSTMENTS WERE MADE TO THE BOLUS AMOUNT FOR IOB AS A BLOOD GLUCOSE LEVEL WAS NOT ENTERED. THE PATIENT USES THE OMNIPOD 5 APP, AND REPORTED HIS PHONE WAS IN A POCKET AT THE TIME OF EVENT AND THE APP OPENED UP ON ITS OWN. THE PATIENT REPORTED HIS LAST INTERACTION WITH THE OMNIPOD APP PRIOR TO THE UNCOMMANDED BOLUS WAS AROUND 12:30PM WHEN HE DELIVERED A BOLUS FOR LUNCH. THE UNCOMMANDED BOLUS WAS REPORTED TO HAVE OCCURRED AT 3:54PM THE SAME DAY. THE PATIENT NOTED HE RECENTLY UPDATED THE SOFTWARE ON HIS SAMSUNG GALAXY S21, TO ANDROID 15. THE PATIENT DENIED PROGRAMMING THE BOLUS. THE OMNIPOD 5 APP SHOWED IOB (INSULIN ON BOARD) OF 7.54 UNITS AFTER THE OMNIPOD SYSTEM HAD STARTED TO DELIVER THE UNCOMMANDED BOLUS. THE PATIENT'S MAX BOLUS IS SET TO 20 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127274 ↗
• MalfunctionMay 28, 2025Unintended System Motion; Unintended System Motion

  THE PATIENT REPORTED ON (B)(6) 2025 HE RECEIVED AN UNCOMMANDED BOLUS OF 13 UNITS FROM HIS OMNIPOD 5 APP (IOS) RESULTING IN HYPOGLYCEMIA. THE PATIENT REPORTED HIS DEXCOM CGM SHOWED HIS GLUCOSE LEVEL TO BE 91 MG/DL AND WHEN HE TESTED HIS BLOOD GLUCOSE WITH A BLOOD GLUCOSE METER, IT WAS ACTUALLY 44 MG/DL. HE REPORTED HE COULD HEAR HIS POD CLICKING AS IT DOES WHEN IT DELIVERS INSULIN. AT THE TIME THE PATIENT WAS REPORTING THE ISSUE TO PRODUCT SUPPORT HE HAD 7 UNITS OF IOB (INSULIN ON BOARD). THE SCREEN SHOWED THE LAST BOLUS DELIVERED WAS 13 UNITS AND WAS GIVEN AROUND 2:30PM. THE PATIENT REPORTED THE LAST BOLUS HE PROGRAMMED AND DELIVERED WAS AROUND 11AM-12PM FOR LUNCH, AND IT WAS FOR 4 UNITS. SYMPTOMS AND TREATMENT INFORMATION WERE NOT PROVIDED. THE PATIENT DID NOT REQUIRE ANY MEDICAL TREATMENT. DATA LOGS FROM THE USER WERE UPLOADED FOR INVESTIGATION.

  Patient problems: Hypoglycemia

  MAUDE report 22096196 ↗
• MalfunctionMay 19, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED BY THE PATIENT THAT WHEN A BOLUS IS PROGRAMMED IN THE OMNIPOD 5 APP FOR ANDROID, ONLY ABOUT HALF OF THE BOLUS IS DELIVERED. THE PATIENT REPORTED THEY HAVE TYPICALLY BEEN ABLE TO CONTROL THEIR BLOOD GLUCOSE LEVELS WELL; HOWEVER, THEY WERE RECENTLY DIAGNOSED WITH FATTY LIVER DISEASE, AND PRESCRIBED MEDICATION. THEY ARE NOW SEEING BLOOD GLUCOSE READINGS OF 400 MG/DL WHILE WEARING THE POD. NO SYMPTOMS ASSOCIATED WITH HYPERGLYCEMIA WERE PROVIDED. THE PATIENT ALSO REPORTED RECEIVING LOW BLOOD GLUCOSE ALERTS IN THE APP WHEN HER BLOOD GLUCOSE IS NOT LOW (127 MG/DL). NO MEDICAL ATTENTION WAS REQUIRED. THE PATIENT UPLOADED THEIR DATA LOGS FOR INVESTIGATION.

  Patient problems: Hyperglycemia

  MAUDE report 22043403 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS RECEIVED ON 30APR2025 THAT REPORTED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR AN ACUTE ILLNESS (NON-DIABETES RELATED). SYMPTOMS INCLUDED ABDOMINAL PAIN, NAUSEA, AND VOMITING. THE PATIENT WAS REPORTED TO HAVE CONTINUED ON THEIR OMINPOD 5 SYSTEM DURING THE DURATION OF HOSPITALIZATION. DURING THE COURSE OF THE HOSPITALIZATION WHILE THE OMNIPOD 5 SYSTEM WAS IN AUTOMATED MODE, THE PATIENT DEVELOPED DKA (DIABETIC KETOACIDOSIS) WITH EUGLYCEMIA. THE HEALTH CARE PROVIDER REPORTED THAT PER THE DOWNLOADED DATA AND THE ELECTRONIC HEALTH RECORD THE PATIENT'S BLOOD GLUCOSE LEVELS WERE IN THEIR TARGET RANGE (70-180 MG/DL) 87% OF THE TIME. THE HEALTH CARE PROVIDED STATED MULTIPLE DEVICES APPEARS IN THE GLOOKO REPORT AND THAT THEY HAD JUST PICKED ONE WHEN PROVIDING THE DEVICE SERIAL NUMBERS. GPM (GLOBAL PRODUCT MONITORING) LATER SPOKE WITH THE PATIENT AND CONFIRMED THE CORRECT SERIAL NUMBER THAT WAS WORN DURING HOSPITALIZATION. IN THE REPORT, IT WAS STATED THAT THE OMNIPOD 5 SYSTEM APPEARED TO HAVE BEEN PAUSED FOR LONG PERIODS OF TIME WHILE IN EUGLYCEMIA, EXCEPT WHEN THE PATIENT WAS GIVEN DEXAMETHASONE IN THE OPERATING ROOM WHICH INCREASED THEIR GLUCOSE LEVELS, AND THEIR

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 21961976 ↗
• MalfunctionMay 1, 2025Unintended System Motion; Unintended System Motion

  THE PATIENT REPORTED RECEIVING A MEMORY CORRUPTION ERROR FROM HIS OMNIPOD 5 APP THAT HE USES ON HIS IOS PHONE THAT TOLD HIM TO REPLACE THE POD. HE UNINSTALLED THEN REINSTALLED THE OMNIPOD 5 APP TO CLEAR THE ALARM AND STATED WITHOUT ANY INTERACTION ON HIS PART, WHEN THE SYSTEM STARTED BACK UP, IT DELIVERED A TOTAL OF 19 UNITS OF INSULIN. PATIENT REPORTED HE PUT THE SYSTEM IN ACTIVITY MODE BECAUSE IT WAS DELIVERING TOO MUCH INSULIN. PATIENT REPORTED CONSUMING 10 GLUCOSE PACKETS TO KEEP HIMSELF FROM "CRASHING". HE REPORTED IT INITIALLY GAVE 16 UNITS THEN WITHIN 10 MINUTES IT GAVE ANOTHER 3 UNITS. NO IMPACT TO BLOOD GLUCOSE LEVELS WAS PROVIDED. THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943734 ↗