Device Problem
Retraction Problem (1536)
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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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging that the piston rod was not retracting.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 03/18/2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2016 with the following findings: on investigation, the alleged motor rewind issue was not duplicated in the evaluation.Review of black box data did not find any rewind issue related alarm.The pump powered up and functioned properly.A rewind/load/prime sequence was and a 24-hour basal exercise were executed without any rewind issues.Pump casing was opened and no evidence of corrosion or damages on the motor connector wire were found.
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Search Alerts/Recalls
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