Model Number G8 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineer was dispatched on (b)(6) 2016.The fse replaced the uptake check valve and rebuilt the pump.No further action required by field service.The g8 analyzer was functioning as intended with all errors cleared.The most probable cause of the reported event was pump unit, fault of failure of inlet check valve.This report is being submitted due to a retrospective review conducted under capa(b)(4).
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Event Description
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On (b)(6) 2016 a customer reported may need check valves replaced with the g8 analyzer.The customer is unable to run hba1c patient samples.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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