OMNIPOD 5 PODS
Report
- Report Number
- 3014585508-2026-16519
- Event Type
- Injury
- Date Received
- March 30, 2026
- Date of Event
- January 30, 2026
- Report Date
- March 27, 2026
- Manufacturer
- INSULET CORPORATION
- Product Code
- QFG
- UDI-DI
- 20385083000579
- PMA / PMN Number
- K231826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
REPORT ASSOCIATED WITH MEDWATCH MW5183511 RECEIVED 04-MAR-2026. ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE PHYSICAL DEVICE WAS NOT RETURNED FOR INVESTIGATION. CLOUD DATA FOR THE PERIOD OF (B)(6) 2025 WAS DOWNLOADED FOR REVIEW. INSPECTION OF THE PATIENT HISTORY BUFFER (PHB)AND POD MANAGER HISTORY (PMH) FILES IDENTIFIED FOUR PODS USED DURING THIS PERIOD WITH SERIAL NUMBERS (B)(6). THE POD WITH SERIAL NUMBER (B)(6) WAS ACTIVATED AT 21:41 ON (B)(6) 2026 AND IMMEDIATELY ENTERED AUTOMATED MODE: LIMITED FOR THE EXPECTED INITIAL 20-MINUTE PERIOD. THE SYSTEM THEN ALTERNATED BETWEEN AUTOMATED MODE AND AUTOMATED MODE: LIMITED DUE TO INTERMITTENT ¿1 ESTIMATED GLUCOSE VALUES (EGVS), INDICATING A FAILURE TO CONNECT BETWEEN THE POD AND CONTINUOUS GLUCOSE MONITOR (CGM). NO BOLUSES WERE DELIVERED BY THIS POD. THE POD WAS DEACTIVATED AT 04:14 ON (B)(6) 2026. A NEW POD WITH SERIAL NUMBER (B)(6) WAS ACTIVATED AT 04:20 ON (B)(6) 2026. A 0.85 U BOLUS WAS DELIVERED IMMEDIATELY FOLLOWING ACTIVATION AT 04:20, AND A SECOND 4.6 U BOLUS WAS DELIVERED AT 05:56. THE SYSTEM BEGAN IN AUTOMATED MODE: LIMITED FOR THE FIRST 20 MINUTES, THEN TRANSITIONED TO AUTOMATED MODE. AT 07:31 ON (B)(6) 2026 THE POD WAS FOUND TO GENERATE AN ALARM WITH ERROR CODE 19-02403-01351-064. THIS INDICATES THAT THE POD GENERATED AN 0X40 HAZARD ALARM INDICATING ROTATIONAL SENSOR MAXIMUM OPEN COUNT EXCEEDED. THE EXACT CAUSE OF THIS ALARM COULD NOT BE DETERMINED FROM THE CLOUD DATA. THE POD WAS DEACTIVATED AT 07:41 ON (B)(6) 2026. A NEW POD WITH SERIAL NUMBER (B)(6) WAS ACTIVATED AT 07:49 ON (B)(6) 2026. THIS POD WAS FOUND TO DELIVER 22 DIFFERENT BOLUSES WHICH RANGED BETWEEN 0.35 U AND 9.75U. THE SYSTEM WAS OPERATING IN AUTOMATED MODE: LIMITED FOR THE FIRST 20 MINUTES, AS EXPECTED, BEFORE TRANSITIONING TO AUTOMATED MODE FOR THE DURATION OF THE POD USE. THIS POD WAS DEACTIVATED AT 20:41 ON (B)(6) 2026. FINALLY, A POD WITH SERIAL NUMBER (B)(6) WAS ACTIVATED AT 20:44 ON (B)(6) 2026 AND WAS FOUND TO BE OPERATING ENTIRELY IN MANUAL MODE, DELIVERING AT THE USER'S SET BASAL RATE BETWEEN 1.2¿1.4 U/HR AS PROGRAMMED. A 7.85 U BOLUS WAS DELIVERED AT 07:10 ON (B)(6) 2026. THE POD WAS DEACTIVATED AT 07:39 ON (B)(6) 2026. ALL PODS WERE SHOWN TO BE SUCCESSFULLY DEACTIVATED, AND NO DISCARDED PODS WERE SEEN. FOR ALL PODS, THE PULSES DELIVERED BY THE POD MATCHES UP WITH THE TOTAL VOLUME OF EACH BOLUS, INDICATING BOTH BOLUSES WERE FULLY DELIVERED. WHILE IN AUTOMATED MODE: LIMITED, THE SYSTEM WAS DELIVERING AT THE LOWER OF THE USER'S MANUAL MODE AND ADAPTIVE BASAL RATE, AS EXPECTED. WHILE IN AUTOMATED MODE, THE SYSTEM WAS CORRECTLY ADJUSTING SUGGESTED INSULIN BASED ON EGVS AND WAS FOUND TO BE DELIVERING AT THE MAX RATE SEVERAL TIMES DURING THE POD'S RUN IN RESPONSE TO HIGH EGVS RECEIVED. NO ISSUES WERE FOUND WITH INSULIN DELIVERY BASED ON THE AVAILABLE CLOUD DATA. HOWEVER, WITHOUT THE RETURNED PODS, IT COULD NOT BE DETERMINED IF THERE WERE ISSUES THAT WOULD HAVE PREVENTED INSULIN DELIVERY AND THE CAUSE OF THE GENERATION OF THE HAZARD ALARM COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. CLOUD - LOCKED DOWN/SMARTPHONE PHONE_CONTROL_IOS. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 2.1.0. CLOUD - OPERATING SYSTEM 26.0. CLOUD - HARDWARE IPHONE15.2. CLOUD - 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. "HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]..), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019; 13:614-626. [2] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019; 10:751-755. [3] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019; 21:155-158".
MEDWATCH WAS RECEIVED ON (B)(6) 2026. IT WAS CLARIFIED THAT FOUR PODS HAD BEEN ASSOCIATED WITH HYPERGLYCEMIA. TWO PODS FAILED IN THE EVENING ON VERBATIM "(B)(6) 2026." THE PATIENT'S BLOOD GLUCOSE INCREASED TO 420 MG/DL AND LARGE KETONES IN THEIR URINE. THEY WERE SEEN IN THE EMERGENCY ROOM (ER) WITH HYPERGLYCEMIA ON (B)(6) 2026. SEVERAL CORRECTION BOLUSES OF INSULIN WERE PROGRAMMED; HOWEVER, THESE DID NOT BRING THE PATIENT¿S BLOOD GLUCOSE DOWN AND THEY STARTED VOMITING. IT WAS ALSO REPORTED THAT THE PATIENT HAD A HIGH KETONE LEVEL (NO EXACT VALUES PROVIDED). THE PATIENT WAS TREATED WITH FLUIDS AND ELECTROLYTES. THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE ALSO MONITORED. THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM 5 HOURS LATER. THIS CASE HAD INITIALLY BEEN REPORTED FOR THE PATIENT BEING UNSURE THE POD WAS DELIVERING INSULIN BUT WAS NOT ALLEGED TO BE PART OF THIS EMERGENCY ROOM VISIT AT THAT TIME SO ORIGINALLY IT HAD BEEN NOT REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783500 | OMNIPOD 5 PODS | OMNIPOD 5 PODS | QFG | INSULET CORPORATION | PT-001662 | PH1U08162531 | 20385083000579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Male | Required Intervention |