MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problem Priming Problem (4040)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported event.Fse confirmed the complaint and was unable to reproduce the problem due to intermittently failing.While troubleshooting, fse found signs of leakage when priming the analyzer while reviewing the wash syringe plungers.Fse resolved the complaint by replacing the wash syringe.Fse repaired and 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 the serial number (b)(6) from (b)(6) 2022 through aware date (b)(6) 2023.There were no similar complaints identified during the search period.The aia-900 operator's manual under section12: error messages states the following: (2239) bf probe 1 purge failure cause: the overflow sensor 1 s132 failed to detect liquid after the washer was discharged.Action: it is conceivable that air has entered the washer tube.Prime the tube and bleed off the air.Check the remaining quality of washer, check to see if there is air in the washer tube, and check s132, the discharge solenoid valve sv150, and the washer tube.(2240) bf probe 2 purge failure cause: the overflow sensor 2 s133 failed to detect liquid after the washer was discharged.Action: it is conceivable that air has entered the washer tube.Prime the tube and bleed off the air.Check the remaining quality of washer, check to see if there is air in the washer tube, and check s133, the discharge solenoid valve sv151, and the washer tube.The most probable cause of the reported event was due to the faulty wash syringe.

Event Description

A customer reported intermittent error messages ¿2239 bf probe 1 purge failure and 2240 bf probe 2 purge failure¿ on the aia-900 analyzer.The customer recently rebooted the analyzer and performed a decontamination.The customer primed the system, made new diluent and wash solutions and repeated the 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 estradiol (e2), beta human chorionic gonadotropin (bhcg), follicle stimulating hormone (fsh), luteinizing hormone (lh ii), prolactin (prl) and progesterone (prog iii) per wi-00004 ¿ delayed result reportability determination.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Device returned to manufacturer? no.Part was not evaluated due to instrument service center (isc) not receiving part.Part lost in transit, therefore no further investigation needed.

• 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: 17322482
• MDR Text Key: 319757722
• Report Number: 3004529019-2023-00371
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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