Device evaluation: the pump has been returned and evaluated by product analysis on 07/07/2016 with the following findings: investigation revealed an intermittently responsive audio bolus button.Upon removal of the bolus button cover, contaminants were found on the contact.In addition, the battery compartment was cracked and the display was dim and discolored.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)(6).
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