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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas alleging that the display screen was dim.There was no indication that the device 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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The correct date of evaluation by product analysis is 1/28/2017.
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Manufacturer Narrative
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Follow-up # 1 date of submission 2/16/2017 device evaluation: the device has been returned and evaluated by product analysis on 1/26/2017 with the following findings: during visual inspection of the pump, it was observed that the pump was returned with a dim and discolored display.Unrelated to the initial complaint, it was observed that the battery compartment was cracked.The battery cap and cartridge cap were not returned with the pump and a test cap was used to complete 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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