Device Problems
Poor Quality Image (1408); 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) 2015, the reporter contacted animas, alleging a display (damaged) issue; display screen is scratched.It was not possible to determine if the screen could be read safely at the time the complaint was received.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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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.Device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2015 with the following findings: on investigation, the display lens was found to be scratched.The display was dim and discolored.Investigation duplicated the complaint.
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Search Alerts/Recalls
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