On (b)(6) 2016, the reporter contacted animas, alleging a button/keypad (tactile changes w/moisture) issue.It was reported that the keypad was unresponsive after the pump was exposed to water.This complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery.There was no indication that the product caused or contributed to an adverse event.
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Follow-up #1: date of submission 06/29/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/08/2016 with the following findings: investigation revealed an intact keypad with fully responsive buttons.Upon removal of the keypad cover, no contamination was found under the contacts.A leak test was performed and failed due to a pump case crack.The pump was opened up and evidence of moisture was found on the main printed circuit board and the keypad circuit, inside the cover, on the display screen and on the continuous glucose monitoring flex.Unrelated to the original complaint, the pump case was cracked in two places.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.
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