MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) followed up with the customer over the phone to address the reported event and confirmed the complaint with the customer by reviewing the error log.Fse instructed the customer to perform a software version up (software reboot) and a hardware reboot, which resolved the complaint.Fse could not determine the cause of the reported event.The customer validated the analyzer by successfully performing daily check and 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 for similar complaints was performed for serial number (b)(6) from (b)(6) 2022 through aware date (b)(6) 2023.There were no similar complaints identified during the search period.Aia-2000 operator's manual on the appendix 4: error messages: (4041) sorter y-axis home detection failure cause: the home sensor failed to activate after the sorter 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.The most probable cause of the reported event is not determined, cause not established.

Event Description

A customer reported error message ¿4041 sorter y-axis home detection¿ on the aia-2000 analyzer.Prior to the call, the customer restarted and re-homed the analyzer, as well as checking for obstructions, 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 creatine kinase mb isoenzyme (ck-mb) and cardiac troponin i (ctnl).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
• Type of Device: 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: 17814745
• MDR Text Key: 324230566
• Report Number: 3004529019-2023-00427
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1