Device Problems
Crack (1135); 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 that the battery compartment was cracked and moisture was present.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 09/07/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/09/2016 with the following findings: the battery compartment was found to be cracked and there was moisture corrosion visible on the inside.The pump failed a leak test as a result of the battery compartment crack.
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Search Alerts/Recalls
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