Device Problem
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 (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 09/12/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/17/2016 with the following findings: pump powers up to a blank screen; unable to perform steps on (b)(6) 2011 due to blank screen.Evidence of moisture visible behind display lens.Leak test failed due to case crack leak.Crack between case seal and keypad cover; crack between case seal and display lens corner.Opened pump; evidence of moisture throughout pump internally.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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