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 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed a clogged waste chute and was able to reproduce the issue by operating the system.The fse cleaned the waste chute and noted cups were no longer trapped in the waste chute.The system initialized and functioned normally.Controls were within specifications.The aia-2000 analyzer returned to operation.No further action required by field service.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2018 to aware date 28oct2019.One other similar complaint was identified during the search period.The aia-2000 operator's manual states the following: [4193] y-axis cup transfer z-axis home overrun cause: the home sensor activated improperly after movement of the y-axis cup transfer z-axis.If this occurs, the current measurement result will be flagged (mf flag) and new measurements will be suspended.Solution: contact tosoh service center or local representatives.The probable cause of the issue is attributed to clog in the waste chute.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 getting waste chute clogging error 4193, y-axis cup transfer z-axis home overrun, on the aia-2000 analyzer.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of intact parathyroid hormone (ipth) patient results.There was no indication of patient intervention or adverse health consequences due to the 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: 9386328
• MDR Text Key: 194647541
• Report Number: 8031673-2019-00484
• 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: 11/27/2019

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: 10/28/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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