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.
|
|
Event Description
|
On (b)(6) 2018, the reporter contacted animas, alleging that the display screen was dim and discolored.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 serious injury associated with this complaint.
|
|
Manufacturer Narrative
|
Device evaluation: the device has been returned and evaluated by product analysis on 12-sep-2018 with the following findings: during investigation, the pump was powered up to a dim display.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
|
|
Search Alerts/Recalls
|