Model Number G8 |
Device Problem
Mechanical Problem (1384)
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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 field service engineer (fse) evaluated the analyzer at the customer's site.Fse resoled the issue by replacing the flow cell.The analyzer was operational.No further action was required by fse.The replaced part was returned and received at the site on 02-apr-2019.
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Event Description
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This report summarizes 1 malfunction event on the g8 analyzer.The review of the event indicated that the g8 analyzer experienced a peak pattern error message, which caused delayed reporting of critical patient test results.There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results.This event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.
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Manufacturer Narrative
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Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.The flow cell unit was returned to the instrument service center for evaluation of this event.Functional testing was performed on the part by performing precision testing with whole blood samples in an effort to duplicate the errors.The results of the testing were acceptable.The error could not be replicated.The part passed testing.The most probable cause of the reported event could not be determined.The part passed testing.Corrected data: h6 evaluation codes: 213-no device problem found 4315- cause not established.
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Search Alerts/Recalls
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