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 11/11/2016, the reporter contacted animas, alleging a history/settings (history/settings issue) issue; the reporter alleged the pump is "going off" with a message saying this if not touched in 16 hours, the pump will shut off.During troubleshooting with animas customer technical support, it was verified that the pump is enabled and set for 16 hours; however, the reporter stated the patient is touching her pump within that time frame; she is using advanced features and entering her carbohydrates and blood glucose levels into the pump.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.This complaint is being reported because the alleged issue has the potential to result in long-term cessation of insulin delivery to the patient.
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Manufacturer Narrative
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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.Device evaluation: the device has been returned and evaluated by product analysis on 01/18/2017 with the following findings: review of the pumps user settings shows the auto-off was set 16 hours; black box showed an auto-off alarm on (b)(6) 2016 at 09:41, (b)(6) 2016 at 03:47, (b)(6) 2016 at 00:38.No evidence of button presses 16 hours prior to the auto-off alarms were observed.Auto-off duration was set "on" with 1-hour duration for testing purposes.The pump set to run on 1 unite per hour basal rate.The pump gave the appropriate auto-off visible and audible alert exactly after 1 hour.The auto-off feature was found to be functioning properly.Unable to duplicate the complaint.On examination, the pump was intact and without damage.On testing, the pump powered on normally.The pump was exercised for 24 hours without error, alarm, warning or malfunction.The pump was determined to be operating as intended and within the required specifications.
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Search Alerts/Recalls
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