Device Problem
Poor Quality Image (1408)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
|
|
Manufacturer Narrative
|
Follow-up #1: date of submission 07/28/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/14/2016 with the following findings:
during investigation, the pump powered on to a dim and discolored display.
|
|
Search Alerts/Recalls
|