FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
MDR report key: 23920362
·
Received December 30, 2025
Report
- Report Number
- 3004464228-2025-64649
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Date of Event
- December 8, 2025
- Report Date
- December 31, 2025
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 20385082000020
- PMA / PMN Number
- K211575
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS A VALID PRODUCT LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 0
IT WAS REPORTED BY THE PRESTATAIRE THAT A NEEDLE MECHANISM FAILURE OCCURRED. THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 330 MG/DL. NO MEDICAL ASSISTANCE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem · 0
IT WAS REPORTED BY THE PRESTATAIRE THAT A NEEDLE MECHANISM FAILURE OCCURRED. THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 330 MG/DL. THE POD WAS WORN BETWEEN 1 AND 4 HOURS. NO MEDICAL ASSISTANCE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2197402 | OMNIPOD DASH INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 18320 | 20385082000020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |