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

Model Number AIA-900

Device Problem Failure to Align (2522)

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

Event Date 05/30/2023

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.While fse was performing a rack rotation, fse found the pitch flag sensor to be out of alignment.Fse adjusted the pitch sensor for x1 to the proper alignment.Fse repaired and validated the analyzer by successfully performing rack rotation, ran quality control run without errors and within acceptable ranges.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 (b)(6) 2022.A complaint history review and service history review for similar complaints was performed from installation date (b)(6).2022 through aware date (b)(6) 2023.There were no other similar complaints identified during this searched period.The aia-900 operator's manual under section12: error messages states the following: (2300) s loader step feed failure cause: the pitch sensor s071 failed to go on after the step feed.Action: check to see if there is any impediment to the sample rack feed.If the trouble reoccurs, contact the tosoh local representatives.Check s071 and the step feed mechanism.The most probable cause of the reported event was due to the pitch flag sensor for x1 was out of alignment.

Event Description

A customer reported error message ¿2300 s loader step feed failure¿ when loading the sample racks on the aia-900 analyzer.The customer check for obstructions and no spills were present.The customer also performed an all-set-home and eject sample racks successfully with no issues.When the customer performed a startup, the analyzer made an audible grinding noise when the customer tried to load the rack.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), estradiol (e2), follicle stimulating hormone (fsh), luteinizing hormone (lh ii), progesterone (prog ii) and intact parathyroid hormone (ipth) per wi-00004 ¿ delayed result reportability determination and creatine kinase mb isoenzyme (ck-mb) and cardiac troponin i (ctnl 2).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: 17160066
• MDR Text Key: 317732748
• Report Number: 3004529019-2023-00348
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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