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

Model Number AIA-2000 ST

Device Problem Computer Software Problem (1112)

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

Event Date 08/04/2023

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 and reproduced the error by loading the aia-2000 software.Fse suspected the aia-2000 software was corrupted and reinstalled it, which resolved the error.Fse repaired and validated the analyzer by successfully performing daily check and quality control run without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from (b)(6) 2022 through aware date (b)(6) 2023.There were no similar complaints identified during the search period.Aia-2000 operator's manual chapter 2: system configuration and functionality, page 4 file configuration the aia-2000 system program is stored in the c:\maxia folder on the c: drive of the controller pc.The c:\maxia folder consists of the following directory structure.(1) c:\ maxia \ documents \ location of electronic documentation (in pdf format).(2) c:\ maxia \ log \ contains log files to which system operation information is automatically saved.These log files will be compressed at system close and saved in the folder c:\maxia\log\backup\ as the file "date.Lzh", which represents the date when the system was closed.(3) c:\ maxia \ mainte \ contains system maintenance program files.(4) c:\ maxia \ resource \ contains system character and image resources.(5) c:\ maxia \ system \ contains the database required for system operation and various related database files.(6) c:\ maxia \ settings \ contains system startup parameter files.The most probable cause of the reported event was due to corruption of the aia-2000 software.

Event Description

A customer reported ¿software problem¿ on the aia-2000 analyzer.The customer stated during startup, the computer was slow and when using the maxia folder (used to view the error logs) the error ¿maxia function: frmdlg_errorviewer; load error data error number:2147217911, description: record cannot be read; no read permission on error log occurred.¿ when the customer exits the error message box, it displays an empty error log and the aia-2000 software closes and the desktop will display.Technical support specialist (tss) instructed the customer to power everything off and was able to perform the daily check.Tss followed up with the customer and the customer was able to load samples and start two assays, but the status bar went gray and not picking up samples anymore.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 progesterone iii (prog iii), estradiol (e2), follicle stimulating hormone (fsh), luteinizing hormone (lh ii), prolactin (prl), and 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.

• 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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 17639018
• MDR Text Key: 322162202
• Report Number: 3004529019-2023-00402
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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