MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000 ST; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem with the customer.Fse saw no dropped cups, but noticed that the bf probe was not discarding all of the wash from the wash station due to a restriction of flow to the 2-way valve.Fse replaced the bf probe #1 and the 2-way valve and ran quality control and samples with no errors.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 operators manual under appendix 4: error messages state the following: [2163] y-axis cup transfer cup release failure cause : the cup-gripping sensor detected a cup after the cup release operation.Solution : contact tosoh service center or local representatives.[2183] x-axis cup transfer cup release failure cause : the cup-gripping sensor detected a cup after the cup release operation was performed.Solution : contact tosoh service center or local representatives.The most probable cause of the reported event was due to a failure of the bf probe and 2-way valve.

Event Description

A customer reported error message "2163 y-axis cup transfer cup release failure" and "2183 x-axis cup transfer cup release failure" on the aia-2000 analyzer.Technical support specialist (tss) had the customer inspect the analyzer and found a dropped cup in the tips tray area.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 beta human chorionic gonadotropin (bhcg), follicle stimulating hormone (fsh), luteinizing hormone (lh ii), intact parathyroid hormone (ipth), and cardiac troponin i (ctnl 2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Event Description

A customer reported error message "2163 y-axis cup transfer cup release failure", "2183 x-axis cup transfer cup release failure", "2142 failed to detect cup from sorter on cup - tip lane", and "4063 sorter tip pickup z-axis home overrun" on the aia-2000 analyzer.Technical support specialist (tss) had the customer inspect the analyzer and found a dropped cup in the tips tray area.The analyzer is down.

Manufacturer Narrative

Corrected data: some of the errors reported by the customer and their associated labelling information were not stated in the initial submission.The aia-2000 operators manual under appendix 4: error messages state the following: [2142] failed to detect cup from sorter on cup - tip lane cause : the cup sensor failed to detect a cup from the sorter on the cup - tip lane.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.[4063] sorter tip pickup z-axis home overrun cause : the home sensor activated improperly following movement of the z-axis sorter tip pickup.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.

• Brand Name: AIA-2000 ST
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 17971358
• MDR Text Key: 326365514
• Report Number: 3004529019-2023-00440
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1