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

Model Number AIA-2000 ST

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 09/27/2023

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 reviewing the error logs.While troubleshooting, fs found debris in the leak sensor (s311) and b/f # 1 z-axis was not moving properly.Fse removed the debris from the leak sensor (s311) and replaced the b/f #1 plus motor cable, cleaned the sample nozzle and substrate tip as routine maintenance.Fse repaired and validated the analyzer by successfully performing quality control run without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from (b)(6) 2022 through aware date (b)(6) 2023.There were no similar complaints identified during the search period.Aia-2000 operator's manual on the appendix 4: error messages: (3005) leak sensor detected leakage.Cause: the leak sensor under b/f unit detected leakage.Measurement is suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to the failure of the b/f #1 plus motor cable and debris from the leak sensor (s311).

Event Description

A customer reported error message ¿3005 leak sensor detected leakage¿ on the aia-2000 analyzer.The customer also reported an audible grinding noise when prompting the analyzer to open the bf probe area.The customer stated the tips were not saturated and the wells are not draining; there were also no kinked tubes, no obstructions, and the waste was not full.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 intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-2000
• 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: 17982398
• MDR Text Key: 327252148
• Report Number: 3004529019-2023-00443
• 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
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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