Model Number G8 |
Device Problems
Device Displays Incorrect Message (2591); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2016, fse arrived at the site to address the reported event.Fse replaced the sample needle, step motor, and large syringe the device was tested and no errors were noted.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of the large syringe.
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Event Description
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On (b)(6) 2016, the customer reported a motor hum follow by a "syr l error" with their g8 analyzer.The error appeared to occur more often when the device had not been in use for a while.The customer stated they had also cleaned & lubricated the drive gear and checked the needle loop but the issue remain unresolved.On (b)(6) 2016, the customer called back to report that they had changed the buffer, added hemolysis wash (h/w), and primed the device but were still receiving errors.On (b)(6) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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Search Alerts/Recalls
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