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

Model Number AIA-2000 ST

Device Problem Obstruction of Flow (2423)

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

Event Date 01/31/2023

Event Type  malfunction  

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 running a test sample.Fse checked the clog sensitivity on the pressure board of the main arm and found the offset sensitivity value was lower than specification and attempted to adjust it but the value would not change.Fse restarted the analyzer, but the offset value still did not change and could not adjust it.Fse replaced the pressure board and still could not adjust the offset sensitivity.Fse then detached the tubing to the sample nozzle and was then able to adjust the sensitivity.Fse found the sample nozzle clogged and replaced the sample nozzle when cleaning didn't seem to help.Fse resolved the complaint by replacing the sample nozzle and adjusting the clog sensitivity 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-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were three (3) similar complaints identified during the searched period, which includes this event.The aia-2000 operator's manual under appendix 4: error messages states the following: [2070] clogging detected during specimen suction by main arm cause : the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution : verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube, and retry the measurement.If retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event is due to clog in sample nozzle and faulty pressure board.

Event Description

A customer reported getting error message "2070 clogging detected during specimen suction by main arm" on the aia-2000 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 estradiol (e2), follicle stimulating hormone (fsh) and progesterone (progiii).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: 16458090
• MDR Text Key: 310989838
• Report Number: 3004529019-2023-00268
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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: 01/31/2023
• 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