Device Problem
No Display/Image (1183)
|
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 12/19/2016, the reporter contacted animas, alleging a display (blank screen) issue.The reporter alleged that the display screen was blank.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of delivery.
|
|
Manufacturer Narrative
|
Device evaluation: the device has been returned and evaluated by product analysis on 1/27/2017 with the following findings: during investigation, the display was fully functional, clear and legible.The display screen was not blank.The pump cover was removed and no internal moisture or defects to the display screen were observed.The original complaint was unable to be duplicated.
|
|
Search Alerts/Recalls
|