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

Model Number	AIA-360 IMMUNOASSAY ANALYZER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was at the customer¿s site to address the reported event and confirmed no temperature on wash heater and confirmed it on the error logs.The fse measured all temperatures and found a thermal issue and replaced the wash heater assembly and adjusted the temperature to 39-degree celsius.The fse repaired and validated the analyzer by successfully performing daily check, quality control run without error, and within acceptable range.No further action required by field service.The aia-360 analyzer is functioning as expected.Capa escalation: a 13 month retrospective review revealed six (6) occurrences of complaints across five (5) separate serial numbers related to "error 3003 waiting for temperature" for the aia-360 analyzer.Data assessment determined the reported error was mostly due to a thermal problem of the wash heater, thermistor turn table, and turn table heater; or a deformation problem of the sample nozzle and turn table sample tube holder springs.All causes of the reported error was corrected prior to reporting patient sample results.There is no indication of a systemic issue and there is no impact to patient safety, therefore no further escalation required.The aia-360 operator's manual under section7-1: error messages states the following: (3003) waiting for temperature description: waiting for the temperature to rise troubleshooting: wait until the temperature rises to correct temperature.The most probable cause of the reported event was due to thermal issue of the wash heater assembly.
Event or Problem Description
A customer reported error message ¿3003 waiting for temperature¿ on the aia-360 analyzer.The customer restarted the analyzer, but the error persists.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 progesterone (prog iii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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: janefrances ajiduah ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 25368516
• Report Number: 3004529019-2026-00071
• Device Sequence Number: 18511297
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/02/2026

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
• 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: 05/05/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2018
• 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