OMNIPOD 5 POD
Report
- Report Number
- 3004464228-2022-18582
- Event Type
- Malfunction
- Date Received
- October 5, 2022
- Date of Event
- September 22, 2022
- Report Date
- September 22, 2022
- Manufacturer
- INSULET CORPORATION
- Product Code
- QFG
- PMA / PMN Number
- K203768
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000536 TO PT-000435. CATALOG NO CHANGED FROM UNAVAILABLE TO POD-BLE-H1-520. UNIQUE IDENTIFIER (UDI) # CHANGED TO (01)10385083000114(11)220330(17)230930(10)PP1K03302231(21)581279. CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K203768.
IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE CANNULA WAS REPORTEDLY BENT AND DID NOT INSERT INTO THE INSERTION SITE. THE POD WAS WORN FOR BETWEEN 4 AND 24 HOURS. NO ADVERSE PATIENT IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1076444 | OMNIPOD 5 POD | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | INSULET CORPORATION | PT-000435 | PP1K03302231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |