Device Problems
No Display/Image (1183); Structural Problem (2506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 reported that the display screen was scratched and could not be read safely.There was no indication that the product 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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The device has been returned and evaluated by product analysis on 02/08/2017 with the following findings: investigation revealed that the display lens was scratched/ unrelated to the original complaint, investigation revealed that the audio bolus button cover was damaged but the button remained responsive, and the battery compartment was cracked in two places.
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Search Alerts/Recalls
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