Device Problem
Poor Quality Image (1408)
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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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.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 08/15/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/20/2016 with the following findings: product evaluation was conducted and the alleged complaint could not be verified or duplicated as the display was clear and legible.Unrelated to the original complaint, the battery compartment was noted to be cracked.In addition, the audio bolus button cover was damaged; however, the bolus button was responsive during the investigation.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.
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Search Alerts/Recalls
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