Device Problem
Device Stops Intermittently (1599)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The pump 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) 2016, the reporter contacted animas, alleging a power (intermittent power) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
|
|
Manufacturer Narrative
|
Follow-up #1 date of submission 04/26/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 04/14/2016 with the following findings: a review of the black box data showed multiple unexplained reboots on 03/14/2016.A visual inspection of the pump showed that the battery compartment was cracked.No battery cap was returned with the pump; a test cap was able to fully secure on to the pump to maintain an electrical connection.The pump successfully passed the ez prime steps.The pump was exercised for 24 hours with no power interruptions or alarms.The pump cover was opened and moisture corrosion was found to the printed circuit board and continuous glucose monitoring module.
|
|
Search Alerts/Recalls
|