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	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) conducted a site visit and was able to confirm the problem by reviewing the error log.Fse was unable to move the main arm, due to the reagent tray door being broken off of the analyzer.Customer informed fse that the unit was broken for several days and they ran on the unit by placing the broken door into position on the reagent tray, which would activate the unit.When the door is off, the analyzer will not move its main arm as a safety precaution.Fse acquired proper parts from instrument service center (isc) and repaired unit.The analyzer also suffered a power surge that destroyed the operating system hard drive, requiring repair.Fse replaced the operating system hard drive and validated the analyzer with quality control (qc) material.The aia-2000 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number 80040802.There were no similar complaints identified during the search period.The aia-2000 operators manual under appendix 4: error messages state the following: [4211] main arm y-axis home detection failure cause : the home sensor failed to activate after the main arm y-axis moved toward the home position.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.4224] interference of dispensing nozzle z-axis of main arm cause : there is a possibility that the dispensing nozzle was interfered with an obstacle such as cap of primary tube.The measurement result will be flagged with the ss flag.Or a command or adjustment value (p05, 191-210) was given for movement beyond the maximum movable distance of the main arm z-axis in the maintenance operation.Solution : remove an obstacle such as cap of primary tube, if any.The most probable cause of the reported event was due to a power surge that destroyed the operating system hard drive.
Event or Problem Description
A customer reported error messages "4211 main arm y-axis home detection failure and 4224 main arm z-axis limit overrun¿ on the aia-2000 analyzer.The customer restarted the analyzer and performed an all set home, but the arm did not move.Technical support specialist (tss) had customer check for obstruction in waste or probe, none found.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 alpha-fetoprotein (afp).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Additional Manufacturer Narrative
Correction to section h6: in the initial submission, component code: "tip" was selected, and is now been corrected to "computer hardware" and "sensor" corrected to "cover".

• 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: 17284314
• Report Number: 3004529019-2023-00364
• Device Sequence Number: 20389346
• Product Code: KHO
• UDI-Device Identifier: 04560189284623
• UDI-Public: 04560189284623
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 08/31/2023

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: 06/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/09/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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