Device Problem
Image Display Error/Artifact (1304)
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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.The device has not been returned to animas.
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Event Description
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On (b)(6) 2016, 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: 2/1/2017.Device evaluation: the device has been returned and evaluated by product analysis on 01/10/2017 with the following findings: unable to investigate display issue, as additional failure prevents adequate investigation.Pump was returned with a blank display.Opened pump- oled was found to be cracked.Test display screen operated properly.
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Search Alerts/Recalls
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