Device Problems
Electrical /Electronic Property Problem (1198); 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 been returned to animas but 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) 2016, the reporter contacted animas, alleging a power (moisture ingress) issue.There was reportedly moisture and corrosion in the battery compartment.There was no indication of damage to the pump.There was no indication that the product caused or contributed to an adverse event.This is reportable because the user may be unaware that the pump has lost power, leading to under delivery.
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Manufacturer Narrative
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Follow-up #1: date of submission 01/05/2017.Device evaluation:
the device has been returned and evaluated by product analysis on 12/20/2016 with the following findings:
during testing, the pump did not power on due to moisture damage in the form of rust and corrosion in the battery compartment; the complaint was duplicated.A visual inspection of the pump revealed a cracked battery compartment.A leak test was performed and failed due to a battery compartment leak.The pump case was removed, and no further moisture damage or other damage was observed to the pump interior or power circuit.Unrelated to the complaint, the bolus button cover was punctured.
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Search Alerts/Recalls
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