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

Model Number AIA-2000 LA

Device Problem Mechanical Problem (1384)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem by observing and feeling the wash probe wobble and observing the white sleeve on the bf probe.The fse replaced the washing probe assembly and verified the resolution by successfully running quality controls.The aia-2000 analyzer is functioning as expected.No further action is 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 similar complaints identified during the search period.The most probable cause of the reported event was due to a faulty washing probe assembly.

Event Description

A customer reported "wash probe number one (1) is loose" on the aia-2000 analyzer.When the customer performed daily maintenance, they noticed the probe was not stable and had a lot of wiggle room.The customer also noticed a white piece on the probe that was loose.The piece was previously able to be tightened to limit movement, but the screw is now stripped, not allowing it to secure wash probe number one (1).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

The washing probe assembly was returned to the tosoh instrument service center for investigation.A visual inspection failed due to wear and deformation of the inside tube and corrosion around the probe.The washing probe appears dirty and yellow (instead of clear), which can cause clogging.In addition, the washing probe assembly screw was stripped and was unable to lock the wash probe into position.Due to the observed damage, additional testing was unable to be performed.The most probable cause of the reported event was due to the faulty washing probe assembly.

• Brand Name: AIA-2000 LA
• 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: 18872237
• MDR Text Key: 337512450
• Report Number: 3004529019-2024-00521
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284623
• UDI-Public: 04560189284623
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 LA
• Device Catalogue Number: 022101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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