Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: a field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the reported error by reviewing the error logs, and reproduced the error while attempting to do a tip detach exercise in maintenance.Fse resolved the complaint by realigning the tip detach stainless plate, and adjusting eki board to specification.Fse successfully validated instrument by performing quality control run without error, and results were within acceptable range.No further action required by field service.The aia-2000 instrument 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 similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: 2061; tip detachment failure by main arm.Cause: a tip was detected by tip detachment check.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to misaligned tip detach stainless plate, and eki board needed adjustment.
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A customer reported getting error message "2061 tip detachment failure by main arm" on the aia-2000 instrument.Prior to calling technical support specialist (tss), the customer inspected the sample probe, and soaked it in alcohol; checked for any dropped tips; inspected waste chute for any obstruction; rebooted the instrument and performed a version up but error persisted.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for alpha-fetoprotein (afp).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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