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

Model Number AIA-2000 ST

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

A customer reported ¿consistent leak above the waste container¿ on the aia-2000 analyzer.The customer is unable to locate the exact location of the leak, 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).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 waste liquid was leaking from the top of the waste tank.Fse visually saw the waste tubing was disconnected from the bottom of the waste canister inside the analyzer.The fse resolved the complaint by reattaching the waste tubing to the bottom of the waste container that was caused by friction.Fse repaired and validated the analyzer by successfully performing runs without leaks and quality control within acceptable ranges.No further action required by field service.The aia-2000 analyzer is functioning as expected.The aia-2000, serial number (b)(6), was installed on 09nov2023.A complaint and service history review for similar complaints was performed from installation date 09nov2023 through aware date 07mar2024.There were no other similar complaints identified during the searched period.The most probable cause of the reported event was due to friction problem that caused the waste fluid tubing to disconnect.

• 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: 19001252
• MDR Text Key: 339013887
• Report Number: 3004529019-2024-00525
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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