(b)(4).Device evaluation by manufacturer: on 27-mar-2018, a field service engineer (fse) was at customer's site to resolve reported event.Fse inspected instrument and noted the guide rods were clean.Fse replaced the sampler z axis assembly and did all alignment checks and adjustments.Fse successfully ran patient tube samples and quality control.Customer ran racks of patient samples successfully without error.The g8 instrument is operating as expected.No further action was required by the fse.A (b)(4) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were four (4) similar complaints identified during the searched period, which includes this event.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 6.3 error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.The 710 z1-axis error: an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The most probable cause of the reported event was due faulty sampler bearings.
|
On (b)(46 2018, a customer reported getting 710 z-axis error messages while running controls on the g8 instrument.The customer stated she cleaned the guide rods and repeated the controls; controls ran without error and completed within acceptable range.Customer wants to monitor instrument before final call closure.On (b)(6) 2018, technical support specialist (tss) followed up with customer, and customer reported screeching noise prior to z-axis error reoccurring.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
|
H.10.Additional manufacturer narrative: tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.The sample assembly was returned for investigation on 24may2018.Visual inspection confirmed the part to be damaged.Part will be discarded.H.3.Device evaluation by manufacturer: the most probable cause of the reported event was due to missing sampler guide sleeve.
|