Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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) 2018, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.There was no indication that the product caused or contributed to an adverse event.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.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 28-dec-2018 with the following findings: during investigation, the pump was powered up to a dim and faded display with a red hue.Unrelated to the original complaint, the battery compartment was cracked from the threads to the grip pad.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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