OMNIPOD 5 CONTROLLER
Report
- Report Number
- 3004464228-2022-20296
- Event Type
- Malfunction
- Date Received
- October 31, 2022
- Date of Event
- October 15, 2022
- Report Date
- October 15, 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 THERMAL EVENT THAT MELTED THE CONTROLLER. 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 CONTROLLER. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP. D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG. CORRECTION TO D (4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO (B)(4). CATALOG NO CHANGED FROM UNAVAILABLE TO SKT-H001-G-X9. UNIQUE IDENTIFIER (UDI)# CHANGED TO (B)(4). CORRECTION TO G (5): PMA/510(K)# CHANGED FROM UNAVAILABLE TO K203768.
IT WAS REPORTED BY THE PATIENT THAT THE CONTROLLERS CHARGING CORD AND PORT WAS MELTED WHEN IT WAS PLUGGED IN. THE FIRST CORD AND CONTROLLER WAS REPLACED BY THE PHARMACY. IT WAS REPORTED THAT THE PATIENTS BLOOD GLUCOSE LEVELS WAS AT 131 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2912453 | OMNIPOD 5 CONTROLLER | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | INSULET CORPORATION | PT-000408 | H000427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Male |