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

Model Number AIA-2000 ST

Device Problem Mechanical Problem (1384)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

A customer reported error message ¿4163 x-axis cup transfer z-axis home overrun¿ on the aia-2000 st analyzer.The customer looked for dropped cups, checked the waster bin and chute, powered off analyzer and performed an all set home, but the error persists.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 beta human chorionic gonadotropin (bhcg), estradiol (e2), follicle stimulating hormone (fsh), luteinizing hormone (lh ii), intact parathyroid hormone (ipth), progesterone (prog iii).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) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the error logs.The fse opened the incubator, performed cleaning and lubrication on the roller bearings of the rotors.Fse identified wear problem on the incubator table collar, replaced the incubator table (rotor), and performed alignments.Fse repaired and validated the analyzer by running cup transfer macro.In addition, fse successfully performed quality control run without error and results were within acceptable range.No further action required by field service.The aia-2000 st 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.Aia-2000 operator's manual on the appendix 4: error messages: (4163) x-axis cup transfer z-axis home overrun cause: the home sensor activated improperly after movement of the x-axis cup transfer z-axis.If this occurs, the current measurement result will be flagged (mf flag) and new measurements will be suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to the faulty collar on the incubator table (rotor) and incubator roller bearings on rotors needed lubrication.

Manufacturer Narrative

The incubator assembly was returned to tosoh instrument service center for investigation.Visual inspection confirmed the incubator assembly was damaged, the table rings are missing test cup holders and clips, does not meet specification.Therefore, no additional testing was able to be performed on the returned incubator assembly.The most probable cause of the reported event was due to the faulty incubator assembly.

• Brand Name: AIA-2000 ST
• 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: 18213661
• MDR Text Key: 330013612
• Report Number: 3004529019-2023-00470
• 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,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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