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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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 casing/condition (moisture ingress) issue.It was reported there was moisture in the battery compartment.This complaint is being reported because the reported issue 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.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 08/26/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/29/2016 with the following findings: investigation revealed moisture in the battery compartment.A leak test was performed and failed due to a crack in the battery compartment.The pump was disassembled and no further moisture was found internally.Unrelated to the original compartment, two cracks were discovered in the battery compartment.
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Search Alerts/Recalls
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