Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Fatigue (1849); Hyperglycemia (1905); Urinary Frequency (2275); Polydipsia (2604)
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Event Date 06/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product 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, the reporter contacted animas alleging a blood glucose of 29 mmol/l with symptoms of tiredness, extreme thirst and urination related to frequent persistent occlusion alarms on the pump.Troubleshooting of the event found that the infusion set and cartridges were used per the instructions for use and supplies had been changed since the issue first started.The reporter indicated that the pump's sensitivity was set to high and the delivery speed was set to normal.This report is made based on the allegation that the patient experienced hyperglycemia related to frequent occlusion alarms on the insulin pump.
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Manufacturer Narrative
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Follow-up #1 date of submission 09/08/2016-product analysis: the device was returned and evaluated by product analysis on 08/12/2016 with the following findings: the complaint could not be duplicated or confirmed with investigation.Review of the pump¿s black box revealed occlusion alarms occurring after the alert date.Data relevant to the alleged event was overwritten due to continued pump use.The total daily dose history and basal history were appropriate for the programmed delivery settings.The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm.The force sensor calibration was found to be within specification.The pump passed a delivery accuracy test.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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