Device evaluation: the pump has been returned and evaluated by product analysis on 06/30/2016 with the following findings: during testing, it was observed that the battery compartment was cracked and the display screen was dim and discolored.Unrelated to these issues, the audio bolus button cover was detached.The battery cap was not returned with the pump and a test cap was used to complete the investigation.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).(b)(4).
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