MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 14apr2019 through aware date (b)(6) 2020.There were no similar complaints identified during the searched period.The most probable cause of the reported event was the substrate needed to be primed to remove air from the lines.

Event Description

Customer did not use the aia-360 instrument for 1.5 weeks.Customer had primed the analyzer.The instrument was decontaminated on 23mar2020.The assays that customer had reported are 27.29 and cea.Both had high patient sample recovery.Both were sent to (b)(6) for high confirmation and results were as follows: on the tosoh 360 it was high and on (b)(6) it was low; the low results were expected.27.29 recovered 248/3.Cea recovered 7.5/1.2.Samples were collected in sst tubes but poured off into a transfer tube and run the same day as collected.The high results did not impact patient treatment so there was no change in treatment or even a report to the patient.The account sent the high results out to an independent lab to be confirmed.Both are high sandwich assays.# 27.29: cup lot: j819106, calibrator lot: j739087, calibration date: 4-28-20, cal rates 1 and 6, rate 1=0.541, 0.529+, 0.518, rate 6 = 73.64, 66.72, 72.34.Quality control (qc).Bio rad (br) 54671 = 26.18 tosoh target range mean (ttrm) = 24.09 range 16.06-31.32.Br 54672 - 77.16 ttrm= 60.09 range 42.06-78.2.27.29 br qc 54672 was at the upper end of the range.# cea: cup lot jx10622.Cal lot jx30125.Calibration date: 4-28-20.Cal rates 1 and 2.Cal rate 1 = 0.49.Cal rate 2 = 69.98 - qctr was lower at 56.9 so high cal rate might be high.Quality controls (qc).Br 40381= 2.7 ttrm= 2.7 range 1.9-3.5.Br 40382= 16.7 ttrm= 18.8 range 13.2-24.4.Br 40383 = 35.5 ttrm = 40 range 28.0-52.0.The technical support specialist (tss) sent new calibrator lots to recalibrate assays after a decontamination with 20% decontamination solution of the wash, diluent and substrate ii lines, then recalibrate the assays, repeat controls.The tss followed up with the customer after the decontamination and additional priming of the substrate line.The customer calibrated and ran qc.The qc ran with no errors and were within published ranges.This was not a control issue, this was an analyzer issue.Decontamination, additional priming and calibration resolved the issue.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 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: 10405449
• MDR Text Key: 260275337
• Report Number: 8031673-2020-00141
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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