Device Problems
Loose or Intermittent Connection (1371); Failure to Power Up (1476)
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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.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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Event Description
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On (b)(6) 2016, the reporter contacted animas alleging that the pump had no power.The reporter indicated that the battery cap was not secured appropriately at the time of the event and the cap was unable to be secured appropriately.The reporter indicated that the cap was unable to be removed from the pump as well.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.
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Manufacturer Narrative
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Follow-up #1: date of submission 09/08/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/13/2016 with the following findings: there were no unexpected pump reboot events observed in the pump's black box history.There were cracks in the battery compartment.The returned battery cap could not secure to the pump due to stripped threads.A test battery cap was able to fit to maintain an electrical connection.
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Search Alerts/Recalls
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