Device Problem
No Display/Image (1183)
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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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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 that the display screen was blank.There was no indication that the device caused or contributed to an adverse event.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.
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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 8/30/2016 with the following findings: during investigation, the pump powered up with the display functioning properly therefore the investigation was unable to duplicate the initial complaint about a blank display screen.The pump powered up with a hard call service 006 alarm which is a failure of the electrically erasable programmable read-only memory (ee-prom).This is an ee-prom write failure.Unrelated to the initial complaint, it was observed that the battery compartment was cracked.The complaint was unable to be adequately investigated due to this alarm.
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Search Alerts/Recalls
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