Device Problems
Break (1069); Loose or Intermittent Connection (1371); Moisture Damage (1405)
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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 a casing/condition (damaged cap and case w/moist) issue.It was reported that the battery compartment was damaged and the battery cap was loose.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 06/13/2016.Device evaluation: the pump has been returned and evaluated by product analysis on 05/24/2016 with the following findings: during testing, the battery compartment was observed to be cracked.Evidence of moisture was observed in the battery compartment.The returned battery cap had stripped threads.
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Search Alerts/Recalls
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