Device Problems
Partial Blockage (1065); Device Displays Incorrect Message (2591)
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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 occlusion (frequent/persistent) issue.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm 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 03/20/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/27/2017 with the following findings: there were occlusion alarms observed in the pump's black box.The force at the time of the occlusions was high.The ¿ez-prime¿ steps were performed correctly with no alarms.The pump passed a force calibration check.The pump was exercised for 24 hours with no occlusions occurring.
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Search Alerts/Recalls
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