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 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the error logs.Fse performed a visual inspection of the waste chute and surrounding area and observed the waste chute was clean with no blockages.The fse also performed a detach tip operation several times with tips attached and without tips.After troubleshooting, fse found the tip removal plate was close to the end of the sample nozzle; possibly touching the plate while removing a tip and causing the intermittent error.Fse adjusted the removal plate for proper alignment ensuring that the sample nozzle tip was positioned at centered of the slot.Fse repaired and validated the analyzer by performing several detach tip processes without issue and ran quality control 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 through aware date of event for similar complaints was performed for serial number (b)(6).There were three similar complaints identified during the searched period including this case.The aia-900 operator's manual under section 12 - flags and error messages states the following: (2062) tip removal error cause: a tip was detected during the tip removal check.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: if the trouble reoccurs, contact the tosoh local representatives.The most probable cause of the reported event was due to the misalignment of the tip removal plate but could not determine the cause of the reported event.

Event Description

A customer reported intermittent error message ¿2062 tip removal error¿ on the aia-900 analyzer.The customer also rebooted the analyzer, checked the solid waste was empty, and the sample probe was not obstructed and was clean.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 (bhcg), estradiol (e2), luteinizing hormone (lh ii), progesterone (prog iii).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: 18062620
• MDR Text Key: 327257554
• Report Number: 3004529019-2023-00450
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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