Device Problems
Battery Problem (2885); Moisture or Humidity Problem (2986)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.
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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 06/22/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/10/2016 with the following findings: corrosion was observed in the battery compartment.The pump failed a leak test due to a battery compartment crack.There was no evidence of further moisture ingress on the internal components of the pump.
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Search Alerts/Recalls
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