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.(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.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 01/25/2017.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.Device evaluation: the device has been returned and evaluated by product analysis on 01/09/2017 with the following findings: on investigation, the pump powered on with functioning audio tone and vibration; however, the display screen remained blank.Investigation confirmed the blank display screen.The pump¿s cover was removed, revealing a single eeprom component was found cracked eeprom failure is conclude as the cause for the blank display.
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Search Alerts/Recalls
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