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 11/06/2023

Event Type  malfunction  

Event Description

A customer reported 2161 c.Transfer cup pickup failure error on the aia-900 analyzer during running quality control (qc).The customer removed the cover on the analyzer and cleaned the transfer mechanism, rebooted the analyzer, and re-ran qc, but error recurred.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), follicle stimulating hormone (fsh), intact parathyroid hormone (ipth), and 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.

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and confirmed the reported issue by review of the error logs.The fse checked all c trans adjustments and found the z position was slightly off.The fse also identified the claws were not straight on the test cup pickup assembly.Due to the nature of the error, the fse changed the test cup pick up assembly, cup transfer flat cable, and driver board.The customer ran quality control (qc) with results withing acceptable range.The aia-900 analyzer is functioning as expected.No further action required by field service.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 other similar complaints found during the searched period.The aia-900 operator's manual under section 12: flags and error messages states the following: 2161] c.Transfer cup pickup failure cause: the cup sensor s063 failed to detect the cup after the cup was grasped.Action: please contact the tosoh local representatives.Check s063, the cup pickup position, and the cup pickup operation.The most probable cause of the reported event was due to failure of the cup transfer cable, driver board, and cup transfer assembly.

Manufacturer Narrative

The cup transfer cable, driver board, and cup transfer (picking) assembly were returned to the tosoh instrument service center (isc) for investigation.A visual inspection was performed with no damage found on the parts.Functional testing was performed and confirmed a failure of the cup transfer assembly, during the functional testing the cup transfer assembly exhibited error 4151, c.Trans-z home detect error confirming cause traced to component failure.Functional testing was performed on the transfer cable and driver board with no findings.These parts functioned as expected.The most probable cause of the reported event was due to a faulty test cup picking 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: 18253656
• MDR Text Key: 329572151
• Report Number: 3004529019-2023-00473
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2023
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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