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

Model Number AIA-900

Device Problem Temperature Problem (3022)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

A customer reported getting "2024 detector temp.Malfunction" and "3034 detector temp.L limit error" on the aia-900 analyzer.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 (lhii).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 engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and reproduced error by attempting a quality control(qc) run.While troubleshooting, fse replaced the detector heater board but temperature would not adjust above 23°c and did not resolve the problem.Fse reinstalled the detector heater board and replaced the bfc board, which resolved the problem.Fse was able to then adjust the detector heater to 37.1°c within acceptable range.Fse performed qc run without error and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.The aia-900, serial number (b)(4), was installed on 03mar2021.A complaint history review and service history review for similar complaints was performed from installation date through aware date.There were two (2) similar complaints identified during the searched period, which includes this event.The aia-900 operator's manual under section 12: error messages states the following: [2024] detector temp.Malfunction cause: the detector temperature did not rise adequately at the start of measurement.Action: wait for at least 30 minutes, and if the trouble reoccurs contact the tosoh local representatives.[3034] detector temp.L-limit error cause: the detector temperature fell below the lower limit (standard: 32 c).No further operation will take place.An io flag will be attached to the measurement result.Action: check the heater and also the temperature sensor t200.It is necessary to switch the main power on again.The most probable cause of the reported event is due to failure of the bfc board.

Manufacturer Narrative

The bfc board was returned to tosoh instrument service center for investigation.Functional testing found temperature adjustment failed to respond, confirming the reported failure was due to failure of the bfc board.A review of the device history record (dhr) was conducted for serial number (b)(6), which confirmed that there were no nonconformance, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12791696
• MDR Text Key: 285338949
• Report Number: 3004529019-2021-00061
• 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: 12/28/2021

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
• Device Catalogue Number: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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