Model Number 4628-003 |
Device Problem
Out-Of-Box Failure (2311)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/16/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.Device not returned.
|
|
Event Description
|
It was reported that the customer had just received the pump and it became unresponsive.There was no impact to the customers blood glucose level.It was indicated that the customer would use manual injections as alternate insulin therapy.
|
|
Manufacturer Narrative
|
No failure detected, use error caused or contributed to event was due to shutdown due to use error.
|
|
Search Alerts/Recalls
|