MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-360 IMMUNOASSAY ANALYZER
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported discrepant patient results for beta human chorionic (bhcg) and progesterone (prog iii) on the aia-360 analyzer.On (b)(6) 2026, the result for bhcg was 38.075 miu/ml (acceptable range 0.5-400.0miu/ml).The physician wanted the bhcg sample sent to a reference laboratory (labcorp) due to the high bhcg result.The labcorp result was 18.467 miu/ml and the acceptable range for labcorp is unknown.The customer was concerned of the significant difference between the inhouse result and labcorb values.The customer also stated the controls for both bhcg and prog iii have been drifting out of range.While technical support specialist (tss) was troubleshooting with the customer over the phone, the customer noticed the bhcg test cups had expired; lot f317106 expiration date 02/28/2026.The customer calibrated a new bhcg lot and resolved the bhcg quality control (qc) issue.For prog iii, the result was 19.14 ng/ml (acceptable range 0.10-40.0ng/ml), using test cup lot f71c320, the sample was also sent to labcorp for comparison and labcorp result was 12.1 ng/ml.The prog iii result was within acceptable range, but customer's prog iii expected value was not provided.The customer called back and stated they recalibrated the prog iii test cup lot f71c320 and decontaminated, but the qc remained out of range.There is no indication of any patient intervention or adverse health consequences due to the reported discrepant patient result.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the issue with the customer and discussed maintenance procedures.The customer was using abbot quality control (qc) reference ranges instead of tosoh¿s when looking at the qc references for bhcg and prog iii.Tosoh's quality control (qc) were within acceptable ranges.Fse verified there were no issues with mechanical and fluidic components of the analyzer.The fse validated the analyzer by successfully performing decontamination, calibrations, and run quality control (qc) within acceptable ranges.No further action required by field service.The aia-360 analyzer is operating as expected.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 searched period.A 13-month lot review for progesterone (prog iii) test cup lot# f71c320 from the date of 01mar2025 through the aware date 01apr2026 was performed for similar complaints.There were two similar complaints identified during the search period including this case.A 13-month lot review for beta human chorionic (bhcg) lot number f317106 from the date of 01mar2025 through the aware date 01apr2026 was performed for similar complaints.There were no similar complaints identified during the search period.The most probable cause of the reported event is due to incorrect interpretation of results/data from the customer.

• Brand Name: AIA-360
• 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 ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 25057922
• Report Number: 3004529019-2026-00058
• Device Sequence Number: 9399462
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/01/2026

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-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• 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: 04/01/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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