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	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the reported error by performing a probe wash prime and observing that probe 1 had little suction compared to the other wash probes.The fse observed dirt buildup on the 2-way solenoid valve.The fse cleared the dirt buildup and ran multiple wash primes without errors to verify the resolution.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 of event for similar complaints was performed for serial number (b)(6).There were no similar cases found during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [2235] b/f probe 1 suction failure.Cause : the overflow sensor detected liquid after washer suction action was completed.The measurement result will be flagged (wu flag).Solution : clean b/f probe 1.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event was due to dirt buildup on the 2-way solenoid valve.
Event or Problem Description
A customer reported "2235 b/f probe 1 suction failure" error on the aia-2000 analyzer.The technical support specialist (tss) instructed the customer to remove the wash probe tip, clean and reseat it and visually check the bf probe area.The customer noted liquid in the well and tried priming the bf probes, but probe 1 was sluggish and did not seem to be priming correctly.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) 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: 21213945
• Report Number: 3004529019-2025-00683
• Device Sequence Number: 19699695
• 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): 01/23/2025

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: 01/16/2025
• Initial Report FDA Received Date: 01/22/2025
• 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