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.
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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 impact the user's ability to read some or all of the information on the screen which may result in over or under 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: 01/03/2017.Device evaluation: the device has been returned and evaluated by product analysis on 12/07/2016 with the following findings: on investigation, the pump powered on with functioning auditory tone and vibration to a blank screen.The reported ¿blank screen¿ complaint was duplicated.The pump¿s cover was removed and the u22 eeprom component was found cracked.Eeprom failure is concluded.
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Search Alerts/Recalls
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