MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported error via the error log.The fse was able to reproduce the reported issue by performing a prime wash operation.The fse found the b/f probe sensitivity adjustment to be out of adjustment.The fse adjusted the b/f probe sensitivity for proper sensing.The aia-900 analyzer is functioning as expected.No further action required by field service.A 13-month complaint and service history review for serial number (b)(4) from 09oct2019 through aware date (b)(6) 2020 was performed for similar complaints.There were two similar complaints including this one identified during the search period.The aia-900 operator's manual under section 12 - flags and error messages states the following: [2236] bf probe 2 suction failure.Cause: the overflow sensor 2 s133 detected liquid after a washer suction operation a wu flag will be attached to the measurement result.Action: clean the wash probe 2.Check s133, the waste liquid solenoid valve sv171, the waste liquid tube, and the liquid pump lp173.The most probable cause of the reported event was that the b/f probe sensitivity needed adjustment.

Event Description

Customer called to report error 2236, bf probe 2 suction failure on the aia-900 analyzer.Customer states this is an ongoing issue and that the field service engineer (fse) has been on site.Customer was told that if it happened again, to call for service.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting luteinizing hormone (lh ii) and follicle stimulating hormone (fsh) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-900
• Type of Device: AIA-900
• 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: 10975618
• MDR Text Key: 229999745
• Report Number: 8031673-2020-00360
• 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: 12/09/2020

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-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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