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

Model Number AIA-2000 ST

Device Problem Mechanical Problem (1384)

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

Event Date 10/06/2023

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 and reproduced the error while troubleshooting.Fse checked for any dropped cups and several were found.Fse found test cups intermittently hitting the back of the sample treatment cup (stc) lane cup position, causing a possible alignment issue.Fse went into maxiaconst, wizard and performed the stc left cup sorter position alignment, resolving the issue.After the reported 2145 error was resolved, error 2204 sorter cup pickup failure occurred.Fse verified suction pad was not dirty and performed pressure switch settings.All settings were within specs which pointed to a possible alignment issue.After loading and scanning trays of cups onto the sorter the fse found that the number of actual cups didn't match the number of cups loaded.Fse performed the right position of cup sensing alignment for all cup shelves and moved trays around manually multiple times and removed cups on trays.Fse performed a cup load/scan and all scanned trays and cups matched.Fse validated the analyzer by running over 20 pickup and release cup onto the left position of the stc with no errors occurring.Additionally, fse performed quality control with all results within acceptable range.The customer loaded several racks of samples with no errors occurring and the analyzer ran for several hours the next day with no errors occurring.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 10661309.There were two similar complaints identified during the search period, including this complaint.The aia-2000 operators manual under appendix 4: error messages states the following: [2145] failed to detect cup from sorter on stc lane cause : the cup sensor failed to detect a cup from the sorter on the stc lane.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.[2204] sorter cup pickup failure cause : the cup hold sensor (pressure switch) failed to detect a cup during the cup pickup operation.If the problem persists when the operation is retried, the measurement result will be flagged (mf flag).Solution : ensure that the top face of the test cup is not dirty and that the seal is not deformed.If this error occurs frequently, contact tosoh service center or local representatives.The most probable cause of the reported event was due to an alignment problem of the cup nozzle assembly for the sorter.

Event Description

A customer reported error "2145 failed to detect cup from sorter on stc lane¿ on the aia-2000 analyzer.The customer rebooted and performed a version up, but the error persisted.The customer said the analyzer is dropping the cup after it has picked it up.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: 18036026
• MDR Text Key: 326950531
• Report Number: 3004529019-2023-00448
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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