Device Problem
Retraction Problem (1536)
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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 device 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) 2019, the reporter contacted animas alleging the pump would not perform the rewind step and the piston rod inside the cartridge compartment was not retracting.There is no indication the alleged product issue caused or contributed to an adverse event.No further information was available.Animas customer support made several attempts to follow-up with the reporter to perform troubleshooting of the issue; however, the reporter did not respond to the follow-up attempts.This complaint is being reported because the insulin delivery could be affected.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 08-oct-2019 with the following findings:.During investigation, the complaint regarding rewind not retracting was unable to be duplicated.There was no evidence of rewind alarms or warnings were observed in the black box or alarm history.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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Search Alerts/Recalls
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