MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000 LA; 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	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) confirmed the reported issue by phone.The fse indicated that the cup presence sensor could be sticking, and instructed the customer to clean the presence sensor with an alcohol pad.This freed up the presence sensor, which resolved the issue.The customer validated the analyzer by running quality control with the results within specification.The aia-2000 analyzer is functioning as expected.No further action is required by field service.A complaint and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were no other similar complaints found during the search period.Review of related documentation.The aia-2000 service manual under appendix 4: error messages states the following: [4273] hybrid cup transfer z-axis home overrun cause: the home sensor activated improperly after movement of the hybrid cup transfer z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probably cause was traced to component failure of the cup presence sensor.
Event or Problem Description
A customer reported 4273 hybrid cup transfer z-axis home overrun on the aia-2000 analyzer.The customer verified that the waste bin was not full and indicated that they performed an all set home function, but it would not fully complete.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delay in patient results for 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.
Additional Manufacturer Narrative
Correction for section h10 statement: 13-month complaint and service history review and probable cause statement: incorrect statement: a complaint and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were no other similar complaints found during the search period.Correct statement: a complaint and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were three (3) similar complaints found during the search period, including this one.Correction for section h10 statement: probable cause of the reported event.Incorrect statement: the most probable cause was traced to component failure of the cup presence sensor.Correct statement: the most probable cause of the reported event was due to a faulty cup presence sensor.

• Brand Name: AIA-2000 LA
• 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: 19989915
• Report Number: 3004529019-2024-00599
• Device Sequence Number: 18289168
• 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,Followup
• Report Date (Section B): 08/17/2024

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
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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