MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse was able to reproduce error message 2160 y-axis cup transfer cup detection failure by performing calibration.Fse checked the alignment of the cup transfer to the d-lane and found it slightly misaligned.Fse performed testing on the sorter and was not able to reproduce error message 2204 sorter cup pickup failure.Fse resolved the complaint by aligning the cup transfer to the d-lane but could not determine the cause of the reported event.Fse repaired and 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-900 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.The aia-900 operator's manual under section 12: flags and 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.(2204) sorter cup pickup failure cause: the cup hold sensor (pressure switch) failed to detect a cup during the cup pickup operation.If the problem persists when the operation is retried, the measurement result will be flagged (mf flag).Solution: ensure that the top face of the test cup is not dirty and that the seal is not deformed.If this error occurs frequently, contact tosoh service center or local representatives.The most probable cause of the reported event was due to the misalignment of the test cup picking assembly but could not determine the cause of the reported event.

Event Description

A customer reported error message ¿2160 y-axis cup transfer cup detection failure¿ during calibration on the aia-900 analyzer.The customer verified the solid waste, switched test cups to another position, performed all-set-home, rebooted the analyzer, retried testing, and the error recurred along with receiving another error message ¿2204 sorter cup pickup failure¿.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 cardiac troponin i (ctnl 2), creatine kinase mb (ck-mb).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-900
• 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: 17982395
• MDR Text Key: 326509604
• Report Number: 3004529019-2023-00442
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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