FDA Adverse Event
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 3972875
·
Received August 1, 2014
Report
- Report Number
- 2531779-2014-22063
- Date Received
- August 1, 2014
- Report Date
- July 23, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMITTED: 08/01/2014, DEVICE EVALUATION: ON INVESTIGATION, THE DISPLAY WAS NOTED TO BE DIM, FADED AND DISCOLORED.
Description of Event or Problem · 1
THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014: A DIM, FADED, DISCOLORED DISPLAY SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450643 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |