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Model Number AIA-2000 ST |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
Event Type
malfunction
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Event Description
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A customer reported getting error message "2070 clogging detected during specimen suction by main arm" on the aia-2000 analyzer.The customer stated the sample nozzle was cleaned and no clots found.Technical support specialist (tss) instructed the customer to reboot the analyzer, but error persisted.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for estradiol (e2), follicle stimulating hormone (fsh) and progesterone (prog iii).There is 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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A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and reproduced error by running test samples.Fse checked the clog sense readings for the main arm and it was out of range and resolved the complaint by adjusting vr1 and vr2 on the main arm pressure board.Fse validated the analyzer by successfully performed quality control run without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: [2070] clogging detected during specimen suction by main arm cause : the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution : verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube, and retry the measurement.If retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event is due to main arm pressure board needed adjustment.
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Search Alerts/Recalls
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