Device Problems
No Display/Image (1183); Moisture Damage (1405)
|
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 (blank screen w/moisture) issue.It was alleged that there was moisture behind the display.There was no indication that the device caused or contributed to an adverse event.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.
|
|
Manufacturer Narrative
|
Follow-up #1: date of submission 03/08/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/15/2017 with the following findings: during investigation, there was visible moisture on the display.The blank screen was unable to be duplicated.The display had normal resolution and contrast.A leak test failed from a bolus button leak.The pump was opened and there was moisture corrosion found on the printed circuit board and other internal components.There was no moisture found in the battery compartment.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
|