|
Model Number AIA-2000 ST |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/22/2023 |
Event Type
malfunction
|
Event Description
|
A customer reported error message "3005 leak sensor detected leakage" on the aia-2000 analyzer.The customer cleaned the wash probe, changed the tip and inspected for leakage with none identified.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 alpha-fetoprotein (afp) and beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
|
|
Manufacturer Narrative
|
A field service engineer (fse) conducted a site visit and was able to confirm the problem by review of the error logs.During troubleshooting, the fse tested the bf washer performance to ensure no leaks were detected as well as visually inspecting the leak sensor, which was found to be covered in debris.The fse cleaned the leak sensor, ran a daily check, and quality control (qc) with results within acceptable range.The aia-2000 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [3005] leak sensor detected leakage.Cause : the leak sensor under b/f unit detected leakage.Measurement is suspended.Solution : contact tosoh service center or local representatives.The most probable cause of the reported event was due to debris on the leak sensor.
|
|
Search Alerts/Recalls
|
|
|