Device Problem
Device Issue (2379)
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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 history/settings (history/settings issue) issue; the basal history matches the active basal program settings, however, the basal delivery totals in the total daily doses do not match the active basal program total.There is no known cause for this variation.This complaint is being reported because the reported issue was not resolved with troubleshooting.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 02/13/2017.Device evaluation: the device has been returned and evaluated by product analysis on 01/31/2017 with the following findings: a review of the black box showed the last basal delivery had no interruptions, and the total daily dose added up correctly and reflected the programmed basal rate target.No activity out side the normal use was found.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours and the correct amount of insulin was found after the duration testing.The product delivered within specification.The complaint of the total daily dose not matching the programmed basal rate was unable to be duplicated.Unrelated to the original complaint, the battery compartment was cracked below the grip pad.
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Search Alerts/Recalls
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