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 not been returned to animas.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) 2016, the reporter contacted animas, alleging a 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 10/31/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 10/04/2016 with the following findings: investigators were unable to duplicate the original ¿blank display¿ complaint.The pump powered on to a clear and legible display.No intermittent condition was found on the display flex connector.Unrelated to the original complaint, the battery compartment was noted to be cracked.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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