Follow-up # 1 date of submission 10/06/2016 device evaluation: the device has been returned and evaluated by product analysis on 9/14/2016 with the following findings: during visual inspection of the pump, it was observed that the battery compartment had two cracks.Unrelated to the initial complaint, it was observed that the pump casing was cracked between the case seal and the display lens.Also unrelated to the initial complaint, it was observed that the display screen was dim and discolored and the audio bolus button cover was damaged but it was responsive during 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)(4).
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