Model Number G8 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The field service engineer (fse) was dispatched to address the reported event.The fse learned that the flow rate adjustment were too excessive therefore, the pump was replaced.The fse adjusted the flow rate from 1.19 ml/min to 1.04 ml/min and ran patient samples ten times to determine precision and verify that the flow rate is 1.04 ml/min.Fse ran calibrators and quality controls and results were all within specification and without any errors.The instrument is functioning as intended and was released.No further action is required by the fse.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the 29th of may 2017 through awareness date on the (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual chapter 1 introduction and applications states the following: interpretation of results : the sa1c measuring range is 4.0 - 16.9%.The ideal retention time for sa1c is 0.59 minutes.The ideal retention time for a0 is 0.90 minutes.Results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see "abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.The chromatogram must be examined for any unidentifiable peaks (i.E., p00, p01,) before the a0 peak.Do not report the result if these peaks exist.When there is a question concerning the chromatography, repeat the sample.If the repeated sample also displays unusual characteristics, it is appropriate to evaluate whether the unusual result is due to an abnormal sample, a procedural error, an instrument malfunction or a sample-handling problem.For further information, see the troubleshooting section in this operator's manual (b)(4).
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Event Description
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The customer reported retention time (rt) of 0.62 minutes (range 0.57-0.61 minutes) on quality control (qc) on their g8 instrument.The technical support specialist (tss) advised the customer to adjust the flow rate (ff) from 1.15 ml/min to 1.17 ml/min and reboot the instrument then run sample.Customer called back and indicated that the retention time is still out of range at 0.62-0.63 minutes.Tss requested the customer to adjust the flow rate to 1.19 ml/min; customer will adjust and requested fse to service the instrument.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.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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Device evaluation by manufacturer.The fluid pump was returned for evaluation and can not be found.Item is considered lost and no evaluation can be performed.The most probable cause of the reported issue can not be established.Updated pma/510k.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.
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Manufacturer Narrative
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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.Follow up #2 incorrectly reported that the fluid pump had been lost and therefore the probable cause of the reported event could not be determined.Please note, the fluid pump has now been found.The fluid pump assembly was returned for evaluation.Functional testing was performed on the part by running whole blood samples.The resulting retention time was slow.The reported issue was duplicated.The part failed testing.The most probable cause of the reported event was due to failure of the fluid pump assembly.
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Search Alerts/Recalls
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