Device Problem
Failure to Prime (1492)
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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 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.(b)(4).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a prime (prime issue) issue.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 05/12/2015.Device evaluation: the device has been returned and evaluated by product analysis on 05/04/2016 with the following findings: a review of the pump¿s black box did not reveal any evidence of a ¿no cartridge detected¿ warning.The load step malfunction was not duplicated during the investigation.The force calibration passed within specification.The pump was opened and there was no evidence of physical damage on the force sensor pins.Unrelated to the original complaint, the battery compartment was found to be cracked.
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Search Alerts/Recalls
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