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, and the reported issue was not resolved with troubleshooting.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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Follow-up #1; date of submission: 11/29/2016.The device has been returned and evaluated by product analysis on 11/03/2016 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 with appropriate audible tones and vibration; however, the display screen was blank.The complaint was duplicated.The pump case was removed, and the internal u22 eeprom component was observed to be cracked.Further testing confirmed that the cracked eeprom was not communicating properly, causing a blank screen.(b)(4).
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