MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. (OHIO) AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900 REFURBISHED

Device Problem Mechanical Problem (1384)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

A customer reported error message ¿2232 bf overflow sensor 2 failure¿ on the aia-900 analyzer.The customer stated the error reoccurs during running samples and all the testing is aborted.The error initially occurred when the customer prepared a fresh wash solution the day before and have been having issues since.Technical support specialist (tss) instructed the customer to perform a fresh wash solution and clean the wash probe and retry testing, but the error persists.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), luteinizing hormone (lh ii) 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

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.The fse was able to reproduce the error by priming the bf wash probe 2.While troubleshooting, fse found the wash solution was not present in the wash well and the sensor was giving a false reading.Fse replaced the bf wash probe 2 and was able to prime the bf wash probes without any errors.Fse validated the analyzer by successfully performing quality control run 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 for similar complaints was performed for serial number (b)(6) from 23aug2023 through aware date 23sep2023.There were no similar complaints identified during the search period.The aia-900 operator's manual under section12: error messages states the following: (2232) bf overflow sensor 2 failure cause: the overflow sensor 2 s133 is detecting liquid constantly.Action: please contact the tosoh local representatives.Check s133.The most probable cause of the reported event was due to the faulty bf wash probe 2.

Manufacturer Narrative

Correction for section h10: date range was incorrect.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 23sep2023.There were no similar complaints identified during the search period.

• Brand Name: AIA-900
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 17954402
• MDR Text Key: 326018836
• Report Number: 3005529799-2023-00038
• 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,Followup
• Report Date: 10/27/2023

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-900 REFURBISHED
• Device Catalogue Number: 022930R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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