Model Number G7 |
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 10/16/2015 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineer was dispatched on (b)(6) 2015.The fse ordered a large syringe and replaced large syringe.The fse primed entire flow path and cleaned and lubricated the analyzer.The fse calibrated, ran qc (quality control and performed a precision check all within specification range.The customer resumed operations.The g7 analyzer was functioning as intended with all errors cleared.No further action required from field service.The most probable cause of the reported event was the syringe unit a defective large syringe.(b)(4).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) 2015 a customer reported missing peaks on one large peak on prime samples with the g7 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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