Device Problems
Break (1069); Crack (1135)
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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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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 reported that the display was cracked.There was no indication that the device caused or contributed to an adverse event.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.
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Manufacturer Narrative
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Follow-up #1 date of submission 09/02/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 08/08/2016 with the following findings: during testing, the display lens was observed to be cracked.Unrelated to the complaint, the battery compartment was cracked.The audio bolus button cover was damaged.
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Search Alerts/Recalls
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