MAUDE Adverse Event Report: Tosoh Hi-Tec, Inc. AIA-900; Fluorometer, For Clinical Use

Model Number	AIA-900
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported error ¿4124 sample-z bump¿ on the aia-900 analyzer.Prior to calling technical support specialist (tss), the customer identified multiple tips jammed into the well and cleared the tips.The customer restarted the analyzer and is also receiving errors 4313 wash1-z home overrun, 4323 wash2-z home overrun, 4193 s.Loader-x3 home overrun, 4173 s.Loader-x1 home overrun, and 4183 s.Loader-x2 home overrun.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.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the complaint by power cycling the analyzer and other errors 3123 lp140, lp172 fuse blew, 3132 main f2 +5v fuse blew, 3002 substrate shortage detected, 3003 waste tank full, and 3004 liquid leak detected also occurred.While troubleshooting, the fse identified the f2 fuse on the main board was blown and other boards did not receive power.The fse replaced the main board.The fse powered up the analyzer multiple times, ran quality control (qc) without errors, and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.The aia-900 operator's manual under section 12 - flags and error messages states the following: (4124) sample-z bump cause: the specimen cap rear-end collision sensor s054 was activated while the specimen dispensing arm z was moving toward the home position.A ss flag will be attached to the measurement result.Action: if the cap is on the specimen, remove it and perform measurement once again.If it is not, contact tosoh local representatives.Check s054 and pm051 for a possible malfunction.(4313) wash1-z home overrun cause: the home sensor s130, which is not supposed to be activated after the bf probe 1 moves, was activated.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s130 and also check to see the cause of slipping, and so on, that occurs when pm130 moves to the limit side.(4323) wash2-z home overrun cause: the home sensor s131, which is not supposed to be activated after the bf probe 2 moves, was activated.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s131 and also check to see the cause of slipping, and so on, that occurs when pm131 moves to the limit side.(4193) s.Loader-x3 home overrun cause: the home sensor s0701, which is not supposed to be activated after the sample loader x3-axis moves, was activated.Action: remove the impediment or other cause of the error.Check s0701 and also check to see the cause of slipping, and so on, that occurs when pm072 moves to the limit side.(4173) s.Loader-x1 home overrun cause: the home sensor s070, which is not supposed to be activated after the sample loader x1-axis moves, was activated.No further operation will take place.Action: remove the impediment or other cause of the error.Check s070 and also check to see the cause of slipping, and so on, that occurs when pm070 moves to the limit side.(4183) s.Loader-x2 home overrun cause: the home sensor s073, which is not supposed to be activated after the sample loader x2-axis moves, was activated.Action: remove the impediment or other cause of the error.Check s073 and also check to see the cause of slipping, and so on, that occurs when pm071 moves to the limit side.The most probable cause of the reported event was due to the blown f2 fuse on the main board.

• Brand Name: AIA-900
• 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 ; +1(650)636-8314
• MDR Report Key: 50797385
• Report Number: 3004529019-2026-00131
• Device Sequence Number: 18522841
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/16/2026

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-900
• Device Catalogue Number: 022930
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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