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	01/18/2024
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 the complaint by reviewing the error logs.While troubleshooting, fse found a broken wire that was located between pm241 and bf-8 cable-2 bf probe.Fse replaced the cable-2 bf probe for pulse motor and resolved the complaint.Fse repaired and validated the analyzer by successfully performing quality control run without error and within acceptable range.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 through aware date of event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the searched period.Aia-2000 operator's manual on the appendix 4: error messages: (4451) b/f probe 2 home detection failure cause: the home sensor failed to activate after b/f probe 2 moved toward the home position.The measuring operation is suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to the broken wire (cable-2).
Event or Problem Description
A customer reported error message ¿4451 b/f probe 2 home detection failure¿ on the aia-2000 analyzer.The technical support specialist (tss) instructed the customer to perform a version up (software reload) and reboot 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 beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Additional Manufacturer Narrative
The wire cable-2 bf probe pulse motor was returned to tosoh instrument service center for investigation.Visual inspection could not confirm the reported event was due to failure of the wire.Probable cause is unknown, cause not traced to device.

• 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: 18656035
• Report Number: 3004529019-2024-00509
• Device Sequence Number: 20615075
• 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,Followup
• Report Date (Section B): 03/21/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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