OMNIPOD 5 CONTROLLER
Report
- Report Number
- 3014585508-2026-15346
- Event Type
- Injury
- Date Received
- March 23, 2026
- Date of Event
- February 16, 2026
- Report Date
- March 23, 2026
- Manufacturer
- INSULET CORPORATION
- Product Code
- QFG
- UDI-DI
- 10385083000022
- PMA / PMN Number
- K203768
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THEY PHYSICAL DEVICE WAS NOT RETURNED FOR INVESTIGATION. CLOUD DATA FROM THE USER WAS DOWNLOADED FROM THE CLOUD AND REVIEWED FOR THE PERIOD OF 12FEB2026-19FEB2026. INSPECTION OF THE PATIENT HISTORY BUFFER DATA (PHB) INDICATES THAT THE SYSTEM WAS RECEIVING INVALID ESTIMATED GLUCOSE VALUES (EGVS) INDICATING NO CONNECTION WITH THE POD AND CONTINUOUS GLUCOSE MONITOR (CGM) UNTIL ON (B)(6) 2026. BLOOD GLUCOSE VALUES COULD NOT BE DETERMINED ON (B)(6) 2026 AS A RESULT. DURING THIS TIME, THE SYSTEM WAS CORRECTLY DELIVERING INSULIN AT THE LOWER OF THE USER'S ADAPTIVE BASAL RATE AND MANUAL MODE BASAL RATE, AS EXPECTED. THE SYSTEM EXITED LIMITED MODE ONCE VALID EGVS WERE RECEIVED. AT 17:57 ON (B)(6) 2026, THE EGVS WERE OBSERVED TO DECREASE TO 41 MG/DL BEFORE DECREASING TO THE LOW (UNDER 40 MG/DL) RANGE. THE USER RECEIVED A CORRESPONDING URGENT LOW GLUCOSE ALERT AT THIS TIME. THE AUTOMATED ALGORITHM WAS FOUND TO PROPERLY ADJUST SUGGESTED AUTOMATED MODE INSULIN DELIVERY BASED ON THE RECEIVED EGVS. NO INSTANCE OF INSULIN DELIVERY WAS NOTED BY THE SYSTEM WHEN EGVS WERE BELOW 60 MG/DL. NO OTHER INSTANCES OF THE USER RECEIVING LOW EGVS WERE OBSERVED IN THE PHB DATA. INSPECTION OF THE POD MANAGER HISTORY (PMH) DATA INDICATES THAT THROUGHOUT THIS TIME, MANY DIFFERENT BOLUSES WERE DELIVERED. THE PMH SHOWS THAT THE SIZE OF ALL BOLUSES WERE IN THE TYPICAL RANGE COMPARED TO PREVIOUS BOLUSES DELIVERED. THE BOLUSES VARIED FROM USING USER PROVIDED CARBS AND CGM VALUES INTO THE BOLUS CALCULATOR AS WELL AS BOLUSES SHOWING A USER BOLUS ADJUSTMENT VOLUME. NO ABNORMAL BOLUSES WERE OBSERVED IN THE PMH DATA THAT WOULD BE INDICATIVE OF AN UNCOMMANDED BOLUS HOWEVER WITHOUT FURTHER INFORMATION FROM THE LOG FILES, IT COULD NOT BE CONCLUSIVELY DETERMINED WHETHER THERE WAS USER INTERACTION IN ORDER TO PROGRAM EACH BOLUS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. LOCKED DOWN SMARTPHONE: DATA NOT AVAILABLE. OMNIPOD SOFTWARE APP VERSION: DATA NOT AVAILABLE. SMARTPHONE OPERATING SYSTEM: DATA NOT AVAILABLE. SMARTPHONE HARDWARE: DATA NOT AVAILABLE. CGM SENSOR TYPE: DATA NOT AVAILABLE. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS DECLINED TO LESS THAN 30 MG/DL WHILE WEARING THE POD AN UNSPECIFIED NUMBER OF HOURS. THE PATIENT STATED THAT THEY DID NOT COMMAND A BOLUS, BUT THE POD WAS IN AUTOMATIC MODE AND GAVE A BOLUS ON ITS OWN. THEY REPORTED THAT THEY ¿BECAME COMATOSE¿ AND THE PARAMEDICS WERE CALLED BY THE PATIENT¿S ROOMMATE AND CHILD. THE PARAMEDICS LIKELY ATTEMPTED TO PLACE AN INTRAVENOUS (IV) CATHETER AS THE PATIENT REPORTED ¿BRUISES ALL OVER FROM ATTEMPTS OF IV.¿ THE PATIENT WAS TREATED WITH PLACEMENT OF A NEW POD AND WAS NOT TRANSFERRED TO THE HOSPITAL. IT IS UNCLEAR IF OTHER TREATMENT WAS PROVIDED ON SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 730482 | OMNIPOD 5 CONTROLLER | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | INSULET CORPORATION | PT-001827 | H000609 | 10385083000022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female |