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.There was no indication that the device caused or contributed to an adverse event.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.
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Manufacturer Narrative
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Follow-up #1: date of submission 03/10/2017 device evaluation: the device has been returned and evaluated by product analysis on 02/21/2017 with the following findings: during investigation, the pump was returned with a blank display.There were multiple ¿cs052/cs054¿ alarms observed in the pump alarm history.Unity test code downloader tool application v 1.0.0 was used to upload test code v 1.0.7 to master/slave/periph processors.A u17 slave processor upload was unsuccessful; u17 slave processor failure is concluded.There was no physical damage found on the display screen.The audio tone alarm is inoperable.Opened pump- a cold/cracked solder was found on piezo.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.(b)(4).
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Search Alerts/Recalls
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