Device Problems
Break (1069); Scratched Material (3020)
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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 display (damaged) issue.It was reported that the display screen was scratched and was not able to be read safely.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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Device evaluation: the pump has been returned and evaluated by product analysis on 03/29/2016 with the following findings: during investigation, the display lens was observed to be scratched.Unrelated to the complaint, investigation revealed that the display was dim with discolored text.Also unrelated to the complaint, investigation revealed a crack in the battery compartment.
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Search Alerts/Recalls
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