Device Problems
Break (1069); Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a display (damaged) issue.It was alleged that the display was scratched and it could not be confirmed if the screen could be safely read.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up #1 date of submission 05/09/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 04/28/2016 with the following findings: during testing, the display lens was observed to be scratched.Unrelated to the complaint the battery compartment was cracked.The audio bolus button cover was torn.The display was dim and discolored.
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Search Alerts/Recalls
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