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 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the 4151 error by reviewing the error log and reproduced the error by clicking the all-set-home under the maintenance screen.During troubleshooting, the test cup picking assembly was unable to go back to the home position after going down.The fse replaced the test cup picking assembly and resolved the complaint.The fse verified the resolution by running daily check and quality control (qc) without errors and within specifications.The aia-900 analyzer is functioning as expected.No further action is 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 operators manual under section 12: flags and error messages state 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 due to a faulty test cup picking assembly.

Event Description

A customer reported error message "4151 c.Transfer-z home detect error and grinding noise" on the aia-900 analyzer.The customer ran a full rack of patient samples when the error occurred and shut the instrument down overnight.The customer stated quality control (qc) passed without issues and attempted to empty the test cups from the incubator, but failed.The customer also checked for obstructions of the b/f cover, but nothing appeared to be out of place and the waste chute did not contain any visible obstructions.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) and progesterone (prog iii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The test cup picking assembly was returned to the tosoh instrument service center for investigation.A visual inspection passed with no damage to the part identified.The returned part was placed on an aia-900 analyzer and a test cup pick up was performed, but error 4151 occurred with each test.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.

• 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: 18728602
• MDR Text Key: 336627922
• Report Number: 3004529019-2024-00512
• 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: 03/21/2024

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: 02/16/2024
• 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: 06/01/2020
• 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