MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error log and was able to reproduce the issue.The fse adjusted the bf probe overflow sensor and performed daily check and quality control (qc).Results were within the acceptable ranges.The aia-900 analyzer returned to operation.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4), from (b)(6) 2018 to aware date (b)(6) 2019.No other similar complaints were identified during the search period.The aia-900 operator's manual states the following: [2235] bf probe 1 suction failure cause: the overflow sensor 1 s132 detected liquid after a washer suction operation.A wu flag will be attached to the measurement result.Action: clean the wash probe 1.Check s132, the waste liquid solenoid valve sv170, the waste liquid tube, and the liquid pump lp172.The probable cause of the issue is attributed to a faulty bf probe sensor.

Event Description

A customer reported receiving error message 2235 bf probe 1 suction failure while operating on the aia-900 analyzer.The customer recalibrated but the issue persisted.The customer verified the bf probes and replaced the probe tips, but the error remained.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of estradiol (e2) and beta-human chorionic gonadotropin (bhcg) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• 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 o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9203723
• MDR Text Key: 219780094
• Report Number: 8031673-2019-00401
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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