Device Problem
Crack (1135)
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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 09/19/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/25/2016 with the following findings: there was evidence of moisture in the battery compartment.A leak test failed due to a battery compartment leak.There was a battery compartment crack to the left of the bumper pad from the threads traveling down to the case seal.The audio bolus button was damaged but still responsive.
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Search Alerts/Recalls
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