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 pump has not been returned to animas for evaluation.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 that there was moisture in the battery compartment.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 12/08/2016 device evaluation: the device has been returned and evaluated by product analysis on 11/15/2016 with the following findings: during investigation, visible moisture corrosion was found in the battery compartment.The battery compartment was cracked above the grip pad.Unrelated to the original complaint, the display was dim and pink.A leak test was performed and failed due to the battery compartment crack.The pump was opened to find no moisture.
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Search Alerts/Recalls
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