MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000 ST; 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 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem by reviewing the error log.During troubleshooting, the fse identified the main arm waste chute was backed up.The fse removed the waste chute and cleaned it.The fse validated the analyzer by verifying the tips were falling through the chute, and by running quality control (qc) with results within acceptable range.The aia-2000 analyzer is operating as expected.No further action required by field service.A 13-month complaint history review and service history through aware date of event for similar complaints was performed for serial number (b)(6).There were a total of three (3) similar complaints identified during the searched period, which includes this event.The aia-2000 operators manual under appendix 4: error messages states the following: [4224] interference of dispensing nozzle z-axis of main arm.Cause : there is a possibility that the dispensing nozzle was interfered with an obstacle such as cap of primary tube.The measurement result will be flagged with the ss flag.Or a command or adjustment value (p05, 191-210) was given for movement beyond the maximum movable distance of the main arm z-axis in the maintenance operation.Solution : remove an obstacle such as cap of primary tube, if any.The most probable cause was due to backed up main arm waste chute.

Event Description

A customer reported error 4224 interference of dispensing nozzle z-axis of main arm on the aia-2000 analyzer.The customer emptied the solid waste but observed the waste chute was blocked and was unable to remove the blockage.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), estradiol (e2), follicle stimulating hormone (fsh), and luteinizing hormone (lh ii).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 ST
• 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: 17805390
• MDR Text Key: 324128312
• Report Number: 3004529019-2023-00426
• 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
• Report Date: 09/25/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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