On (b)(6) 2016, the reporter contacted animas, alleging a display (damaged- scratched) issue.This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.There was no indication that the product caused or contributed to an adverse event.
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The device has been returned and evaluated by product analysis on 12/16/2016 with the following findings: during visual inspection of the pump, it was observed that the display lens was scratched.The pump powered up with the with returned battery cap to a dim and discolored display screen.Unrelated to the initial complaint, it was observed that the battery compartment was cracked and the pump case was cracked between the corner of the display lens and the case seal and it was also cracked between the case seal and the keypad.Also unrelated to the initial complaint, it was observed that the audio bolus button cover was damaged but the button was still responsive during the investigation.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.
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