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 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 4127 on the aia-2000 analyzer.The device was being used for diagnosis during the complaint event.At the customer site, a field service engineer (fse) observed that the error is generated while the stc lane is at cup pickup position or at sample nozzle position.The sensor was replaced which resolved the issue.The faulty sensor was due to a component failure.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 serial number (b)(4) from the date of 09aug2020 through aware date 09sep2021 was performed for similar complaints.There were no similar complaints identified during the search period.The aia-2000 operator's manual under section 04 - error messages states the following: [4127] stc lane positioning move overrun.Cause: the positioning sensor activated improperly after movement of the stc lane.Solution: contact tosoh service center or local representatives.

Event Description

Customer reported an error 4127, stc lane positioning move overrun on the aia-2000 analyzer.The error occurs repeatedly during every run.The analyzer is down.This is a reportable event based on delay in reporting of patient results for class 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: 12573932
• MDR Text Key: 275039811
• Report Number: 3004529019-2021-00038
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• 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: 09/09/2021
• 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