Device Problem
Premature Discharge of Battery (1057)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
|
|
Event Description
|
On (b)(6) 2017, the reporter contacted animas, alleging a power (battery life) issue.There was no indication that the product caused or contributed to an adverse event.The issue is being reported because it may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
|
|
Manufacturer Narrative
|
Follow-up #1: date of submission 03/30/2017 device evaluation: the device has been returned and evaluated by product analysis on 03/08/2017 with the following findings: a review of the black box showed evidence a partially discharged battery had been installed and resulted in replace battery alarms.No moisture/corrosion was found in the battery compartment or damage to the battery compartment or returned battery cap.The returned battery cap was able to be fully tightened to the pump to power it on.The rewind, load, and prime steps were performed successfully.The current draws were measured within specifications.The pump cover was removed to find no evidence or loose components inside the pump.The battery life issue was not duplicated during the investigation.(b)(4).
|
|
Search Alerts/Recalls
|