Device Problem
Occlusion Within Device (1423)
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Patient Problems
Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
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Event Type
Injury
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Manufacturer Narrative
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The pump has not been returned to animas.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, animas received notification alleging an absence of occlusion issue with the pump.The patient reportedly experienced multiple high unspecified blood glucose (bg) values with unspecified ketones.The exact bg measurements were no provided.It was noted that the health care provider (hcp) insisted on replacing the pump and the patient resumed insulin pump therapy after it was replaced.This complaint is being reported because the patient experienced hyperglycemia due to the alleged absence of occlusion issue with the pump.
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Manufacturer Narrative
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Follow-up #1: date of submission 06/13/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/24/2016 with the following findings: a review of the alarm history revealed one occlusion alarm on (b)(6) 2016 at 00:28.During investigation, the ezprime sequence was successfully completed.The pump completed a 24 hour duration test with no errors, alarms or warnings duplicated.The pump was manually occluded during testing.The pump displayed an "occlusion alarm detected" message on the screen along with vibrate and audible features.The occlusion alarm feature was found to be functioning properly.The total daily dose added up correctly and reflected the users programmed basal rates.There was no delivery defects found during the delivery accuracy testing.The pump was found to be delivering within required range and delivering accurately.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.
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Search Alerts/Recalls
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