Device Problem
Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 05/08/2016, the reporter contacted animas, alleging a history/settings (history/settings issue) issue; the reporter alleged that the pump "kept reverting back to suspend." this complaint is being reported because as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.There was no indication that the product caused or contributed to an adverse physical event.
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Manufacturer Narrative
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Follow-up #1: date of submission 06/22/2016: device evaluation: the device has been returned and evaluated by product analysis on 06/09/2016 with the following findings: review of the pump history revealed the pump was suspended on the date of the reported issue.On investigation, the pump was exercised for 24 hours without self suspending or any alarms occurring.As part of the investigation, the pump was suspended; the pump gave the appropriate audio and visual suspend alert associated with the suspension.On examination, there was no damage found to the keypad and all buttons responded to presses appropriately.Investigation did duplicate the complaint.
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Search Alerts/Recalls
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