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 (b)(6) 2016, the reporter contacted animas, alleging a display (blank screen) issue.There was no indication that the product 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
|
Device evaluation: the pump has been returned and evaluated by product analysis on 12/05/2016 with the following findings: the pump powered on with intact auditory and vibratory features to a blank screen.The pump¿s cover was removed and corrosion was found to the eeprom.
|
|
Search Alerts/Recalls
|