Model Number G8 |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).On19apr2018, fse arrived at the site to address the reported event.Investigation of the device revealed that the large & small syringe rods and screws were dry and dirty.Fse cleaned and lubricated the large and small syringes and the sampling needle assembly rod and screw.He was subsequently able to run precision, controls, and verify instrument operation.No further issues were noted.No further action was required by field service.A (b)(4) complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the search period.On19apr2018, fse arrived at the site to address the reported event.Investigation of the device revealed that the large & small syringe rods and screws were dry and dirty.Fse cleaned and lubricated the large and small syringes and the sampling needle assembly rod and screw.He was subsequently able to run precision, controls, and verify instrument operation.No further issues were noted.No further action was required by field service.A (b)(64 complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the search period.The g8 variant analysis mode operator's manual under preface safety precautions, states the following: contact technical support: blood to be tested might have been infected by (a) pathogen(s).Misconduct on repair or disposal may bring infection to you or others working together.In the case of repairing and disposing, please contact technical support.The most probable cause of the reported event was due to dirty large syringe rods & screw.
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Event Description
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On (b)(6) 2018, the customer reported a loud, high-pitched, squealing noise during washing with their g8 analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delay in reporting of patient results for hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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Manufacturer Narrative
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Corrected data: device evaluation was inadvertently duplicated on the initial report.On 19apr2018, fse arrived at the site to address the reported event.Investigation of the device revealed that the large & small syringe rods and screws were dry and dirty.Fse cleaned and lubricated the large and small syringes and the sampling needle assembly rod and screw.He was subsequently able to run precision, controls, and verify instrument operation.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the search period.Updated most probable cause: the most probable cause of the reported event was due to dirty large and small syringe rods & screws.(b)(4).
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Search Alerts/Recalls
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