MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed reported errors by reviewing the qc data.Fse noted that the analyzer was due for periodic maintenance (pm) and performed the analyzer pm.During verification of substrate replacement, fse noticed an inconsistent purge of substrate, as well as a slow drip after dispensing.Fse inspected the 3-way substrate solenoid valve and observed debris in the first port of the valve, which receives from the substrate bottle.Fse replaced the 3-way solenoid valve, and successfully validated analyzer by running calibration, precision and qc; all runs completed without errors and within acceptable range.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-360 operator's manual under chapters 9 - 10, provides detailed information on substrate line maintenance procedure.The 3-way solenoid valve was returned to tosoh instrument service center for investigation.Functional testing did not confirm the reported failure.The most probable cause of the reported event could not be reproduced.

Event Description

A customer reported getting out of range high results on quality control (qc) imprecision during sample runs with the aia-360 analyzer.The customer stated qc was rerun with fresh qc material, but that didn't improve the results.The customer also reported hearing noise from carousel turntable.The customer stated some of the reagent test cups on the carousel had fluid on the outside of the cup and fluid on the carousel.Technical support specialist (tss) instructed the customer to verify proper functioning of the waste pump; the customer confirmed waste was going into the waste container and no waste tubing was pinched.Tss then, instructed the customer to inspect the bf probe and run a bf wash prime; the customer confirmed no leaks or fluid found, and tubing were attached.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for cardiac troponin i (ctnl 2).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: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9164956
• MDR Text Key: 220520487
• Report Number: 8031673-2019-00388
• Device Sequence Number: 1
• Product Code: KHO
• 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
• Type of Report: Initial
• Report Date: 10/07/2019

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
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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