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Model Number AIA-360 IMMUNOASSAY ANALYZER |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2022 |
Event Type
malfunction
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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 the noise and error by running diluent prime.The fse noticed squeaky noise was coming from the diluent tower, and error 4013 followed after the noise.The fse found the threads on the drive for the tower were dirty and resolved the complaint by cleaning and lubricating the threads on the diluent tower.Fse performed several diluent primes without error, performed quality control run 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: [4013] spec.Sy home not found is generated when the home position of the specimen syringe motor cannot be detected.The operator is instructed to turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported event is due to dirty threads on the diluent tower (syringe diluent unit).
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Event Description
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A customer reported an intermittent squeaky noise and error message "4013 spec.Sy home found" on the aia-360 analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for estradiol (e2).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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Search Alerts/Recalls
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