Device Problem
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 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.(b)(6).
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Event Description
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On (b)(6) 2017, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing) issue.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 03/16/2017 device evaluation: the device has been returned and evaluated by product analysis on 02/24/2017 with the following findings: during investigation, the battery compartment was found to be cracked.Unrelated to the original complaint, the pump powered on to a dim and discolored display.Additionally, the audio bolus button cover was damaged but still responsive during investigation.
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Search Alerts/Recalls
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