MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Mechanical Problem (1384)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 4163 on the aia-2000 analyzer.The device was being used for diagnosis during the complaint event.By phone, a field service engineer (fse) advised customer to wipe the tip of the cup pick-up arm with alcohol which resolved the issue.This investigation confirmed a mechanical failure due to a maintenance issue.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A 13-month complaint and service history review for (b)(4) from the date of (b)(6) 2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.The aia-2000 operator¿s manual under appendix 4 error messages states the following: [4163] x-axis cup transfer z-axis home overrun cause: the home sensor activated improperly after movement of the x-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.

Event Description

Customer experienced an error 4163 x-axis cup transfer z-axis home overrun on the aia-2000 analyzer.An all set home completed ok.The site cleared the waste bin and chute; however, the error re-occurs after starting a run.This is a reportable event based on delay in reporting of patient results for category a analytes.

• Brand Name: AIA-2000
• 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: 12921302
• MDR Text Key: 287193014
• Report Number: 3004529019-2021-00077
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1