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 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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a display (blank screen) issue.There was no indication that the product 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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Follow-up #1; date of submission: 09/14/2016.The pump was returned and evaluated by product analysis on 08/20/2016 with the following findings.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.During testing, the pump was powered on and the display screen appeared.The complaint was not duplicated; however, the display screen appeared dim with discolored text.Unrelated to the complaint, the battery compartment was observed to be cracked.
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Search Alerts/Recalls
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