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 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 (b)(6)2019, the reporter contacted animas, alleging a motor (rewind issue) issue.The reporter alleged the piston is not rewinding during the rewind, load and prime step.There is no indication the alleged product issue caused or contributed to an adverse event.This complaint is being reported because the user is unable to load the cartridge and the pump cannot be used which may lead to long-term cessation of insulin delivery.
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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 was returned, and investigation completed by product analysis on 22-apr-2019 with the following findings: review of the black box data and pump alarm history confirmed call service 076-0000ea alarms recorded.Due to an unrelated device issue, investigation of the alleged rewind issue was not able to be investigated; the device was received in a condition that prevented the investigation of the alleged product issue.No conclusions can be made at this time.
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Search Alerts/Recalls
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