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 was cracked.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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Follow-up #1: date of submission 03/01/2017 device evaluation: the device has been returned and evaluated by product analysis on 02/08/2017 with the following findings: investigation revealed that both the oled and the display lens were cracked.Unrelated to the original complaint, investigation revealed that the pump would not power on and that there was a defective component on the printed circuit board.
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Search Alerts/Recalls
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