MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. (OHIO) AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900 REFURBISHED

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

(b)(6), acct name: (b)(6).Phone: (b)(6).Urgent?: urgent.Serial#: (b)(4).Msg: it's not working, i am getting error code u053 - z home.Msg: error.It is picking up test cups nad dropping it in the.Msg: empty space next to it.The customer is getting a constant sorter error 4053 sorter z home overrun.The customer has opened the sorter and removed all reagents cups and trays, rebooted the analyzer and the error 4053 persists.The customer is down and they run class a troponin.Dispatched to fse.

Event Description

A customer reported error message 4053 sorter-z home overrun on the aia-900 analyzer.The customer has opened the sorter and removed all reagents cups and trays, rebooted the analyzer and the error still appeared.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 for cardiac troponin i (ctnl2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A correction to section b5 and h10 with additional information.A field service engineer (fse) was at the customer site to address the reported event.At the customer site, fse confirmed the complaint by reviewing the error log and was able to reproduce the error by performing a sorter test.Fse found a misalignment of the sorter pick-up head assembly and resolved the complaint by aligning the sorter pick-up head assembly.Fse performed an adjustment to the sorter pick-up head assembly and ran quality control (qc) without errors and within acceptable range.No further action required by field service engineer.The aia-900 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 26dec2020 through aware date 26jan2022.There were no similar complaints identified during the search period.The aia-900 operator¿s manual section 12: error messages states the following.[4053] sorter-z home overrun cause: the home sensor s022, which is not supposed to be activated after the sorter z-axis moves, was activated.A retry will take place, and if there is no improvement a flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s022 and also check to see the cause of slipping, and so on, that occurs when pm022 moves to the limit side.The most probable cause of the reported event is due to a misalignment of the sorter pick-up assembly.

• Brand Name: AIA-900
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi OH 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: 13721077
• MDR Text Key: 296972377
• Report Number: 3005529799-2022-00023
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900 REFURBISHED
• Device Catalogue Number: 022930R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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