FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1033698
·
Received April 25, 2008
Report
- Report Number
- 2531779-2008-00233
- Event Type
- Injury
- Date Received
- April 25, 2008
- Date of Event
- March 28, 2008
- Report Date
- March 28, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL HAS NOT BEEN COMPLETED. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.
Description of Event or Problem · 1
THE RECEIVED ER TREATMENT FOR ELEVATED BLOOD GLUCOSE LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | 2020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |