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 a casing/condition (moisture ingress) issue.It was alleged 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 01/23/2017.Animas received new information on 13 jan 2017 regarding this complaint.It was reported that the patient wore this insulin pump in a hot tub, which is against the manufacturer's instructions for use.Based on this new information, the complaint is considered to be ruled out for malfunction because the device was used outside the manufacturer's instructions for use.
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Search Alerts/Recalls
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