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) 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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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 12/12/2016 with the following findings:.The pump was returned with scratches on the display lens.Unrelated to the original complaint, the battery compartment was cracked from case seal traveling to grip pad.
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Search Alerts/Recalls
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