FDA Adverse Event
Injury
Summary report: N
OMNIPOD, INFSULIN PUMP
MDR report key: 3853486
·
Received May 28, 2014
Report
- Report Number
- 3004464228-2014-00727
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- April 29, 2014
- Report Date
- April 30, 2014
- Manufacturer
- INSULET CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K122953
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT FOR HYPERGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER'S CLINICAL DIABETES EDUCATOR REPORTED THAT THE CUSTOMER WAS TAKEN TO THE ER WHERE SHE WAS ADMITTED TO THE HOSPITAL. SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS TREATED WITH AN INSULIN DRIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312854 | OMNIPOD, INFSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization |