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Model Number AIA-360 IMMUNOASSAY ANALYZER |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2023 |
Event Type
malfunction
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Event Description
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A customer reported getting error message "4004 turn table slip turntable motor slipping detected" on the aia-360 analyzer.The customer states that the turntable is lifting out of position and crashing.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), luteinizing hormone (lh ii), and prolactin (prl).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 analyzer's report slips, but could not reproduce error.Fse could not find any mechanical constraint, but proactively replaced the home sensor, verified alignment of turntable and cycled several times without errors.Fse successfully performed daily check and quality control runs without error and within acceptable range.No further action required by field service.The aia-360 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-360 operator's manual under chapter 7, section 7.1: list of error messages states the following: [4004] turn table slip is generated when the turntable motor slipped.Turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported event could not be established.
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Search Alerts/Recalls
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