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

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 11/22/2023

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 by inspecting the pick up head (gripper) arms and found one of them broken.The pick up head arm was unable to properly open and close to pick up the test cup.The fse replaced the test cup picking mechanism assembly and performed necessary adjustments to ensure proper functionality.Fse repaired and validated the analyzer by successfully performing test pickup runs and 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 through aware date of event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states the following: (4153) c.Trans-z home overrun cause: the home sensor (b)(6), which is not supposed to be activated after the cup transfer z-axis moves, was activated.No further operation will take place.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check (b)(6) and also check to see the cause of slipping, and so on, that occurs when pm061 moves to the limit side.(2161) c.Transfer cup pickup failure cause: the cup sensor (b)(6) failed to detect the cup after the cup was grasped.Action: please contact the tosoh local representatives.Check (b)(6), the cup pickup position, and the cup pickup operation.The most probable cause of the reported event was due to the faulty test cup picking mechanism assembly.

Event Description

A customer reported ¿4153 c.Trans-z home overrun¿ error while performing start up on the aia-900 analyzer.The customer powered off and on the analyzer, observed the waste bin and no build up of cups noted, but the error persists.Technical support specialist (tss) instructed the customer to perform an all-home-set and reran the daily check and passed with no errors.The customer called back and reported ¿2161 c.Transfer cup pickup failure¿ error message.Tss instructed the customer to observe the waste chute and found build up of waste cups, the customer cleared the blockage from underneath and error 4153 c.Trans-z home overrun reoccurred.Tss also instructed the customer to reboot the analyzer, but errors persist.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 alpha-fetoprotein (afp).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The test cup picking mechanism assembly was returned to tosoh instrument service center for investigation.Visual inspection confirmed the test cup picking mechanism assembly was damaged and could not be tested.The most probable cause of the reported event was due to the faulty test cup picking mechanism assembly.

• 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: 18315409
• MDR Text Key: 330951184
• Report Number: 3004529019-2023-00480
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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