MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; 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	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the error by reviewing the error log.The fse checked the reagent cup-tip lane home sensor (s050) of the pib board and found a loose wire.The fse resoldered the wires to the sensor, resolving the issue.The fse verified the resolution by performing alignments for the cup tip lane and ran controls without error.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) through the aware date.There were no similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4113] reagent (test) cup-tip lane home overrun cause: the home sensor activated improperly after movement of the reagent (test) cup-tip lane.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to a loose reagent cup-tip lane home sensor (s050) wire of the pib board.
Event or Problem Description
A customer reported ¿4113 test cup-tip lane home overrun¿ error on the aia-2000 analyzer.The customer stated no obstructions were observed, the tip tray area was clear and the tips were seated properly.The customer attempted to perform an all-set-home, 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 beta human chorionic gonadotropin (hcg) and hcg (human chorionic gonadotropin).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
• 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: 22172880
• Report Number: 3004529019-2025-00741
• Device Sequence Number: 18487469
• 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): 06/10/2025

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: 05/22/2025
• Initial Report FDA Received Date: 06/09/2025
• 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