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 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.Initial reporter: (b)(6).
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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: 01/10/2017.Device evaluation: the device has been returned and evaluated by product analysis on 01/07/2017 with the following findings: the pump was returned with a fully operable display.The complaint of a blank display could not be duplicated on investigation.A review of the alarm history indicated that multiple call service 052/054 alarms had occurred.These alarms have the ability to make the display screen appear blank.The pump was opened and no internal defects were found.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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