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
|
The reporter contacted animas on 11/17/2016 alleging a display (blank screen) issue.There was no health consequence to the patient associated with the reported incident, and no medical treatment or health care provider intervention was required.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
|
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.Device evaluation: the device has been returned and evaluated by product analysis on 01/09/2017 with the following findings: on investigation, the pump powered on and the display became illuminated per normal operation.Investigation did not duplicate the alleged blank display screen.Unrelated to the original complaint, moisture was found inside the pump on the printed circuit board.
|
|
Search Alerts/Recalls
|