Device Problem
Moisture Damage (1405)
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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.
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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.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 11/15/2016-product analysis: the device was returned and evaluated by product analysis on 10/25/2016 with the following findings: a cartridge compartment crack was observed.No moisture was observed within the cartridge compartment.Leak testing revealed a cartridge compartment leak.Unrelated to the complaint, a battery compartment crack was observed.Moisture was observed on the battery cap.Leak testing did not reveal a battery compartment leak.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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Search Alerts/Recalls
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