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

Model Number AIA-2000 ST

Device Problem Obstruction of Flow (2423)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem by reviewing the error log.Fse inspected the sample nozzle and noticed that it was clogged.Fse resolved the complaint by replacing the sample nozzle and making necessary alignments.Fse validated the analyzer by running a calibration, precision and controls with no issues.The aia-2000 analyzer is functioning as expected.No further action 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 aia-2000 operators manual under appendix 4: error messages state the following: [2070] clogging detected during specimen suction by main arm.Cause: the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution: verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube, and retry the measurement.If retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event was due to clog in the main arm sample nozzle.

Event Description

A customer reported error message "2070 clogging detected during specimen suction by main arm¿ on the aia-2000 analyzer.The customer checked specimen and they did not have fibrin or any visual debris.Customer ran a stylist up the main sample nozzle arm to remove any debris and ran two samples and the main sample arm collided with the bottom of the tube, making a large collision noise twice.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 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: 17667544
• MDR Text Key: 322520882
• Report Number: 3004529019-2023-00405
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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