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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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 motor (rewind issue) issue.It was reported that the piston rod would not retract.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: 02/28/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/06/2017 with the following findings: a review of the black box and alarm history did not find any evidence of a rewind issue.The pump powered on normally and successfully completed ez-prime steps.There was no indication of debris in the cartridge compartment and a 2 ml cartridge was inserted with no issues.The pump was exercised for 24 hours with no issues occurring.The complaint could not be confirmed or duplicated on investigation.Unrelated to the original complaint, investigation revealed that the battery compartment was cracked.
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Search Alerts/Recalls
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