Device Problems
Moisture Damage (1405); Structural Problem (2506)
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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 casing issue.The reporter claimed that the battery compartment was cracked/damaged and there was moisture in the pump.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 09/27/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/30/2016 with the following findings: during investigation, moisture was found in the battery compartment.A crack in the battery compartment was found from the threads to the case seal left of the grip pad.A leak test was performed and failed due to a leak in the battery compartment.The pump was opened to find no further moisture damage.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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