MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

To resolve this issue, the customer decontaminated the reagent lines as part of routine maintenance.The psa was calibrated and qc was ran and the results were in acceptable range.A precision study was ran on the patient specimen and the result was <0.05 which is what the customer was expecting.A psa linearity study was performed and acceptable.The tss suggested that they run the br qc l1 routinely.It would be helpful to confirm the analyte is reporting well at the low end of the psa calibration curve not just twice a year when they run the psa linearity.The aia-360 analyzer is operating as intended.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 14jun2019 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 contamination of the instrument.

Event Description

Customer reported that she ran a patient specimen for prostate specific antigen (psa).The patient had their prostate removed and questioned the sample integrity.The psa result was 0.09, 0.13 and <0.05.The quality control br 85210 l2 was 3.12, 3.16, 3.20.L3 was 17.99, 18.44, 18.19.Both qc l2 and l3 passed.The lab does not run l1 qc.Customer was advised to send out the same specimen to an alternate lab or run a precision study.On august 25, 2020, the technical support specialist (tss) reached out to the customer for an update.The tss was informed of the following: the aia-360 analyzer was decontaminated as part of regular 6 month maintenance schedule.The psa linearity was ran and results were acceptable.The psa was recalibrated after decontaminating the reagent lines, qc br 85210 l2 3.16 and l3 17.99, both results in range.The customer said that she repeated the patient specimen with the new calibration and the patient specimen result was <0.05.She sent out the specimen to two different labs and the specimen and the results compared well.At the time of the call, the customer did not have the data sheets with the exact results; however, she will provide them when available.

• 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: 10878154
• MDR Text Key: 229999741
• Report Number: 8031673-2020-00345
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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