Device Problem
Sticking (1597)
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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 ok button was under responsive.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 09/21/2016 device evaluation: the device has been returned and evaluated by product analysis on 08/27/2016 with the following findings: all of the keypad buttons were responsive.There was no contamination found underneath the button contacts.The alleged issue could not be duplicated.The battery compartment was found to be cracked.
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Search Alerts/Recalls
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