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

Model Number	AIA-2000 LA
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was at the customer's site to address the reported event.The fse confirmed the complaint by reviewing the error log.The fse observed that the 5 volts was not getting to seal breaker home sensor s0 70.The fse repaired loose wire at the sense board cn 26 connector, which resolved the issue.The fse repaired and validated the analyzer by successfully running quality control without error and within acceptable range.No parts returned.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13 month complaint and service history review through the aware date for similar complaints was performed for serial number (b)(6).There were no similar complaints found during the search period.The aia-2000 service manual under appendix 4: error messages states the following: [4143] seal breaker home overrun cause: the home sensor activated improperly after seal breaker movement.If retry fails, the measurement system will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the loose wire at the sense board connector could not be established.
Event or Problem Description
A customer reported 4143 seal breaker home overrun on the aia-2000 analyzer.The analyzer is down and the customer has requested service.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of beta human chorionic gonadotropin (bhcg) 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.

• 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: 20875278
• Report Number: 3004529019-2024-00665
• Device Sequence Number: 12994006
• 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): 12/09/2024

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: 12/01/2024
• Initial Report FDA Received Date: 12/08/2024
• 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