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 01/23/2024

Event Type  malfunction  

Event Description

A customer reported 4151 (900 only) c.Trans-z home detect error on the aia-900 analyzer.The customer verified the waste bin was empty, completed all set home, but the analyzer fails to complete empty test cup action.The customer confirmed cleaning of the cup transfer assembly, but error recurs.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.

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the reported error by review of the error logs.The fse was also able to reproduce the error by running cup transfer.The fse identified a problem homing the cup transfer assembly and a problem with the cup pick up motor.The fse replaced the cup transfer assembly as well as replaced the cup pick up z motor.The fse aligned the cup transfer assembly and performed multiple cup transfer test and ran quality control (qc) with results within specifications and no issues recurring.The aia-900 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 (b)(6).There were no similar complaints identified during the search period.The aia-900 operator's manual under appendix 4: error messages states the following: [4151] c.Trans-z home detect error cause: the home sensor s062 failed to be activated after the transfer y moved toward the home position.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s062 and pm061 for a possible malfunction.The most probable cause of the reported event was failure of the cup transfer assembly and the cup pick up z motor.

Manufacturer Narrative

The test cup picking assembly and cup pick up z motor were returned to the tosoh instrument service center (isc) for investigation.A visual inspection was performed with no damage found on either part.Functional testing via manual operation was performed and confirmed a failure of both parts to meet specifications.This indicates a mechanical problem identified with a failure due to expected or random component failure, without any design or manufacturing issue.The most probable cause of the reported event was due to a faulty test cup picking assembly and cup pick up z motor.

• 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: 18728601
• MDR Text Key: 336625811
• Report Number: 3004529019-2024-00511
• Device Sequence Number: 1
• Product Code: KHO
• 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,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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