Device Problem
Moisture Damage (1405)
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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 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)(6).
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Event Description
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On (b)(6) 2017, the reporter contacted animas, alleging a casing/condition (moisture ingress) issue.It was alleged that there was moisture behind the display.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
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Manufacturer Narrative
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Follow-up #1: date of submission 05/19/2017 device evaluation: the device has been returned and evaluated by product analysis on 05/03/2017 with the following findings: during investigation, visible moisture corrosion was found on the display.A leak test was performed and failed due to a leak around the display lens.The pump was opened to find moisture corrosion on the cartridge housing.No moisture was found in the battery compartment.
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Search Alerts/Recalls
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