Model Number 4628-003 |
Device Problems
Pumping Stopped (1503); Out-Of-Box Failure (2311)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/25/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
|
|
Event Description
|
It was reported that an unspecified malfunction alarm occurred.There was no impact to customer's blood glucose level as customer had not started using the pump for therapy.The customer reported that a backup pump and manual injections would continue to be used for insulin therapy.
|
|
Manufacturer Narrative
|
The failure investigation has been completed.Based on the analysis, the alleged issue was verified and a different issue was identified.
|
|
Search Alerts/Recalls
|