Device Problem
Poor Quality Image (1408)
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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.(b)(6).
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Event Description
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On (b)(6) 2015, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.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 11/09/2015 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2015 with the following findings: the display screen had a pinkish contrast.Unrelated to the complaint, the battery compartment was found to be cracked on the side at the threads.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Search Alerts/Recalls
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