MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360 IMMUNOASSAY ANALYZER; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Mechanical Problem (1384)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) verified the errors with the customer via the telephone from the printout.The customer stated the wash solution was made the week prior to the event and performed fine for the past few days.The customer checked the wash probe tubing and discovered the tubing had popped off the top of the wash probe.The fse had the customer reconnect the wash probe tubing and inspect the sample carousel at the wash well.The customer found magnetic beads in the wash well.The fse had the customer clean out the magnetic beads and the wash well.The customer was then instructed to run the bf prime in maintenance.It ran with no errors.The customer reinstalled the back cover and ran quality control (qc).Qc passed within the acceptable ranges.The instrument returned to operational status.Complaint/service history review: a 13-month complaint history review and service history review for similar complaints was performed for instrument serial number (b)(4) from 6/21/2020 to aware date (b)(6)2021.No other similar complaints were identified during the search period.Review of related documentation: the aia-360 operator¿s manual states the following: [2015] bf probe purge failure description: purging by the bf probe is abnormal.Troubleshooting: clean up the wash probe tip or replace it.Contact the service department.[2016] bf probe suction failure description: suction by the bf probe is abnormal.Troubleshooting: contact the service department.An investigation was performed in response to a complaint of error 2015, bf probe purge failure, and error 2016, bf probe suction failure, on the aia-360 analyzer.The device was being used for diagnosis during the complaint event.Upon further investigation, magnetic beads were discovered in the wash well which attributed to the wash probe tubing coming off the wash probe.The customer cleaned out the magnetic beads from the wash well and resolved the reported issue.System maintenance and quality control (qc) were then performed with passing results.The aia-360 returned to normal operation.In conclusion, this investigation confirmed a failure of the aia-360 analyzer to meet specifications or intended use.The wash probe tubing popped off the wash probe due to the magnetic beads in the wash well which caused obstruction of flow.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.

Event Description

The customer reported receiving error 2015, bf probe purge failure, and error 2016, bf probe suction failure, on the aia-360 analyzer.The customer stated daily check passed on the morning of the event.The tip on the probe was replaced but the errors remained.Field service was notified.A field service engineer (fse) was dispatched to address the reported issue.There was a delay in reporting estradiol (e2) patient results.However, there was no patient intervention or adverse health consequences due to the event.

• Brand Name: AIA-360 IMMUNOASSAY ANALYZER
• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12334702
• MDR Text Key: 267057147
• Report Number: 3004529019-2021-00007
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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