Device Problems
Electrical /Electronic Property Problem (1198); 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 device 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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a power (damage with moisture ingress) issue.It was alleged that the battery compartment was cracked and there was moisture inside it.There was no indication that the product caused or contributed to an adverse event.This issue is being reported 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 02/08/2017 device evaluation: the device has been returned and evaluated by product analysis on 01/19/2017 with the following findings: a review of the black box showed power on reset events.Moisture was found in the battery compartment.The battery cap was able to fit for testing.The pump was able to power on properly.The rewind, load, and prime steps were performed successfully.The pump was exercised for 24 hours and no loss of power issues occurred.A leak test was performed and failed due to a crack in the battery compartment at the threads to the left side of the grip pad down to the seal.The pump was opened to find moisture on the power flex printed circuit board.The loss of power issue was not duplicated during the investigation.(b)(4).
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Search Alerts/Recalls
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