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	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported error 2075 (2000 only) air detected during specimen suction by main arm on the aia-2000 analyzer.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in 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
A field service engineer (fse) prior to arriving at customer site, the fse confirmed with the customer by phone the reported error is 2160 y axis cup transfer detection failure and not 2075 (2000 only) air detected during specimen suction by main arm.The customer stated the system aborts with the reported error.At the customer site, the fse ran cup transfer macro and was unable to reproduce the error due to the error being intermittent.The fse replaced the cup transfer assembly (picking up mechanism) as well as the flex cable to the assembly and performed alignments.The fse validated the analyzer by quality control (qc) with results within acceptable range and also performed sixty (60) test with no errors recurring.The aia-2000 analyzer is operating as expected.No further action required by field service.A 13-month complaint history review and service history through aware date of event for similar complaints was performed for serial number (b)(6).There were no other similar complaints found during the searched period.The aia-2000 operators manual under appendix 4: error messages states the following: [2160] y-axis cup transfer cup detection failure.Cause : the cup-gripping sensor failed to detect a cup prior to cup pickup.The measurement result is flagged with mf or se.Solution : contact tosoh service center or local representatives.The aia-2000 operators manual under appendix 4: error messages states the following: [2075] air detected during specimen suction by main arm cause : after specimen suction, it was determined that the tip failed to touch the liquid surface even though the specimen level was 2 mm or higher than the bottom of the container.If retry fails, the measurement result will be flagged (mf flag).Solution : ensure that the specimen is in the correct position and is free from bubbles.If retry fails, contact tosoh service center or local representatives.The most probable cause of the reported issue was due to failure of the cup transfer assembly and the cup transfer flex cable.

• 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: 17561651
• Report Number: 3004529019-2023-00397
• Device Sequence Number: 6967657
• 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): 09/26/2023

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
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/25/2023
• 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