Device Problem
Image Display Error/Artifact (1304)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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.(b)(6).
|
|
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 issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.There was no indication that the product caused or contributed to an adverse event.
|
|
Manufacturer Narrative
|
The device has been returned and evaluated by product analysis on 1/26/2017 with the following findings: during visual inspection of the pump, it was observed that the display screen was not dim or discolored therefore the initial complaint was not duplicated during the investigation.Unrelated to the initial complaint, it was observed that the battery compartment was cracked.
|
|
Search Alerts/Recalls
|