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 not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas alleging a casing/condition (case damage w/moisture) issue.It was reported that the battery compartment was cracked and there was moisture present in the pump.There is no indication that the product issue 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: 11/30/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 11/07/2016 with the following findings: during investigation, moisture was found in the battery compartment.A leak test was performed and failed due to a crack in the battery compartment along the side.The pump was opened to find no moisture.The battery compartment was also cracked from the case seal to the bumper.A leak was not found at this location.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Search Alerts/Recalls
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