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

Model Number AIA-2000 ST

Device Problems Failure to Align (2522); Deformation Due to Compressive Stress (2889)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

A customer reported error messages ¿4273 hybrid cup transfer z-axis home overrun¿ on the aia-2000 analyzer.The customer rebooted the analyzer but didn't resolve the error.Technical support specialist (tss) instructed the customer to set all modules back home and the error persisted.The customer is unable to complete the daily startup and found fallen test cups on the tips area.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.

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 and also identified error code 2151 hybrid arm /cup transfer cup pickup failure and adjusted the misalignment of the x-1 pitch sensor to resolve error code 2151.While further troubleshooting, fse noticed every time the hybrid picking assembly retrieved a cup from incubator 1, the analyzer consistently failed when fse executed the cup discard function in compound action mode.Fse found the claws on the cup picking assembly bent and not able to pull the cup high enough to activate the sensor.Fse removed the cup picking assembly and was able to reform the pick up claws so they were straight and functioning properly.Fse repaired and validated the analyzer by successfully performing cup discard function in compound action, ran 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 the serial number (b)(6) from 30apr2022 through aware date 31may2023.There were no similar complaints identified during the search period.Aia-2000 operator's manual on the appendix 4: error messages (4273) hybrid cup transfer z-axis home overrun.Cause: the home sensor activated improperly after movement of the hybrid cup transfer z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.(2151) hybrid arm /cup transfer cup pickup failure cause: the cup-gripping sensor failed to detect a cup after the cup pickup operation was performed.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to the failure of the cup pick up mechanism and the misalignment of the x-1 pitch sensor.

• 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: 17177318
• MDR Text Key: 317645624
• Report Number: 3004529019-2023-00353
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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