MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Mechanical Problem (1384)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the errors by reviewing the print outs saved by the customer.Fse was unable to duplicate the problem while onsite.The fse reviewed the service manual and the description of what occurred and suspects the issue was likely related to sensor (s401) or the bf probe up down motor.In addition, the fse cleaned the bf probe assembly, ensure the s401 was triggering normally, added lubrication to the bf probe motor linear slider and worm drive screw, checked bf probe alignment to the wash well and sample cup, and performed several bf wash sequences while watching s401 and the bf motor.Fse could not determine the cause of the reported event.No issues were noted when observing lh calibration, customer samples and quality control.No further action is required by field service.The aia-360 analyzer is functioning as expected.A complaint history review and service history review from the installation date through the aware date of event for similar complaints was performed for serial number (b)(6).There were two similar complaints identified during the search period including this case for both errors 4039 wash probe home not found and 5026 washer task error bf wash solution task execution.The aia-360 operators manual under section 7-1: list of error messages states the following: [4039] wash.Probe home not found description: the home position of the bf probe motor cannot be detected.Troubleshooting: turn the power off and on again.If this problem reoccurs, contact the service department.[5026] washer task error description: bf washing task execution error.Troubleshooting: turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported event was not determined, cause not established.

Event Description

A customer reported error "4039 wash probe home not found¿ and "5026 washer task error bf wash solution task execution error" on the aia-360 analyzer.The customer tried restarting the analyzer, checked the wash and was within specifications, no obstruction was noted, but the error persists.The customer also noted a grinding noise.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) and progesterone (prog iii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-360
• 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: 18628550
• MDR Text Key: 334374039
• Report Number: 3004529019-2024-00505
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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