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

Model Number AIA-900

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported event.The fse confirmed the reported error by reviewing the error logs and reproduced the error by running a sample.During troubleshooting, the fse found test cups stuck in the waste chute.The fse cleared and cleaned the dirt and removed the test cups from the chute.The fse reran the sample and the error did not reoccur.The fse validated the analyzer by successfully performing quality control (qc) and result was within acceptable range.No further action was required by the fse.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)(4) from 22may2021 through aware date 22jun2022.There were no similar complaints identified during the search 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 s062, 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 representative.Check s6062 and also check to see the cause of slipping, and so on, that occurs when pm061 moves to the limit side.The most probable cause of the reported event was due to the waste chute being backed up with dirt.

Event Description

A customer reported repeated error message 4153, c trans z home overrun on the aia-900 analyzer.The site rebooted the analyzer and emptied the waste and the error persist.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for luteinizing hormone (lh ii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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: 14973919
• MDR Text Key: 304377981
• Report Number: 3004529019-2022-00125
• 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
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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