Device Problem
No Display/Image (1183)
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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 for evaluation.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 (blank screen) issue.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of 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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Follow-up #1: date of submission 09/01/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/09/2016 with the following findings: on investigation, the display was not blank; the display was dim/fading and discolored.The pump was opened for investigation; the display was undamaged and the display flex was fully seated in the connector.Investigation did not duplicate the blank display screen complaint.Unrelated to the original complaint, the battery compartment was cracked below the bumper traveling toward the case seal.
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Search Alerts/Recalls
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