MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 2207 on the aia-2000 analyzer.The device was being used for diagnosis during the complaint event.At the customer site, a field service engineer (fse) was able to resolve the problem by replacing the sorter plarail cable.While connecting the cables to the sorter board one of the connectors pin bent so the fse replaced the sorter board.The intermittent break on the plarail cable and the bent connector pins was due to a component failure.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A 13-month complaint and service history review for serial number (b)(4) from the date of(b)(6) 2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4 error messages states the following: 2207 no tip acquired by sorter cause: no tip was detected during the tip attachment check.If retry fails, measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.

Event Description

Customer experienced a tip attach error 2207.The tip picker was cleaned and replaced the tips and trays.The aia-2000 analyzer was rebooted, opened and closed which did not resolve the issue.The tips are not being tossed around the analyzer, it's just not picking the tips up.This is a reportable event based on delay in reporting of patient results for beta human chorionic gonadotropin (bhcg) assay.

• Brand Name: AIA-2000
• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 13049468
• MDR Text Key: 290273660
• Report Number: 3004529019-2021-00086
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1