FDA Adverse Event
Malfunction
Summary report: N
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
MDR report key: 12662022
·
Received October 19, 2021
Report
- Report Number
- 3004464228-2021-18758
- Event Type
- Malfunction
- Date Received
- October 19, 2021
- Date of Event
- October 13, 2021
- Report Date
- October 18, 2021
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- UDI-DI
- 20385082000020
- PMA / PMN Number
- K192659
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
REMOVE FROM D4 - UNIQUE IDENTIFIER (UDI) # = (B)(4). ADD TO D4 - LOT NO = PD1K05132111. ADD TO D4 - EXPIRATION DATE = 11/13/2022. ADD TO H4 - DEVICE MFG DATE = 5/13/2021. ADD TO D4 - UNIQUE IDENTIFIER (UDI) # = (B)(4).
Additional Manufacturer Narrative · 1
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 THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE PATIENT'S BLOOD GLUCOSE (BG) WAS AT 115 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1559219 | OMNIPOD DASH INSULIN MANAGEMENT SYSTEM | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 18320 | 20385082000020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |