On (b)(6) 2016, the reporter contacted animas, alleging that the pump lost power.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
|
Follow-up #1 date of submission 08/15/2016-device evaluation: the pump was returned and evaluated by product analysis on 07/19/2016 with the following findings: 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.A review of the pump black box data revealed no evidence of a power issue.During testing, the battery cap secured properly to the pump to maintain power.The rewind, load, and prime steps were completed with no duplicated power issues.The pump case was removed, and no intermittent conditions were found.The complaint was not duplicated.Unrelated to the complaint, the battery compartment was observed to be cracked.(b)(4).
|