Device Problem
Battery Problem (2885)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
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.(b)(6).
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life) 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 - device evaluation: the pump has been returned and evaluated by product analysis on 04/19/2016 with the following findings: a review of the black box data showed evidence of a short battery life illustrated with a 6 count sudden voltage drop leading to a low battery warning on (b)(6) 2016.A visual inspection of the pump showed that the battery compartment and cap were undamaged.The pump cover was damaged.The pump was able to power on and successfully passed the ez prime steps.The pump¿s current draws were found to be above specifications.The pump cover was opened and component was found to be chipped and damaged.The component was related to the motor boost regulator power supply.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.(b)(4).
|
|
Search Alerts/Recalls
|