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

Model Number	AIA-2000 LA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported error messages 2205 sorter dropped cup and 4043 sorter y-axis home overrun on the aia-2000 analyzer.The customer performed an all set home and checked sorter for dropped or missing cups and found none.The customer then rebooted the analyzer, ran a sample, but error persisted.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 bhcg (beta human chorionic gonadotropin) and human chorionic gonadotropin (hcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Additional Manufacturer Narrative
A field service engineer (fse) conducted a site visit and was able to confirm the reported issue by review of the error logs.The fse inspected the analyzer and identified a reagent cup stuck in the y axis path for the sorter.The fse removed the cup, cleaned and lubricated the sorter and made an alignment adjustment to the sorter third floor cup top z axis.The fse verified the x and y axis for all sorter floors and ran a get cup sorter action twice with no errors occurring.The fse cleaned and lubricated the sample loader and ran a rack rotation test with no errors occurring.The fse validated the analyzer by running 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 80267103.There were no other similar complaints found during the searched period.The aia-2000 operator's manual under appendix 4 error messages states the following: [2205] sorter dropped cup cause : the cup hold sensor (pressure switch) failed to detect a cup after the cup release operation was performed on the cup - tip lane or the stc lane.Sorter operation is suspended.Solution : open the sorter¿s door and remove the dropped cup.Close the sorter¿s door to resume assay.If this error occurs frequently, contact tosoh service center or local representatives.The aia-2000 operator's manual under appendix 4 error messages states the following: [4043] sorter y-axis home overrun cause : the home sensor activated improperly following movement of the sorter y-axis.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.The most probable cause was due to an alignment issue with the cup sorter, component failure.

• Brand Name: AIA-2000
• Common Device Name: 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: 19197405
• Report Number: 3004529019-2024-00545
• Device Sequence Number: 8360664
• Product Code: KHO
• UDI-Device Identifier: 04560189284623
• UDI-Public: 04560189284623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K971103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIA-2000 LA
• Device Catalogue Number: 022101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown