MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) spoke with the customer via the telephone.The customer confirmed that there were no obstructions from stopping the main arm from moving.The fse had the customer power down the analyzer and the pc at the same time, then turn them both on.Afterwards, the customer was able to perform daily check successfully.The customer completed start up, controls and patient samples with no system errors.The aia-2000 analyzer returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 15jun2019 to aware date 15jul2020.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [4211] main arm y-axis home detection failure cause: the home sensor failed to activate after the main arm y-axis moved toward the home position.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The probable cause is attributed to dropped cups which caused a mechanical jam of the main arm.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported receiving error 4211 main arm y-axis home detection failure on the aia-2000 analyzer.The customer had removed jammed cups prior to calling but the error reoccurred.No additional dropped cups were found.A field service engineer (fse) was notified.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting alpha-fetoprotein (afp) and beta-human chorionic gonadotropin (bhcg) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• 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: 10353918
• MDR Text Key: 261202844
• Report Number: 8031673-2020-00210
• 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: 07/28/2020

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-2000
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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