MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 2300 on the aia-900 analyzer.The device was being used for diagnosis during the complaint event.By phone, a field service engineer (fse) was able to resolve the issue by walking customer through re-aligning the flag from the step loader.This investigation confirmed a step loader flag was out of alignment due to a component failure.A 13-month complaint and service history review for serial number (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.There were two complaints reported during this time period that were similar to the present issue including this event.The aia-900 operator¿s manual under section 12: flags and error messages states the following: error message: [2300] s.Loader step feed failure.Cause: the pitch sensor s071 failed to go on after the step feed.Action: check to see if there is any impediment to the sample rack feed.If the trouble reoccurs, contact the tosoh local representatives.Check s071 and the step feed mechanism.

Event Description

Customer experienced an error 2300 s.Loader step feed failure.The sample loader made a loud noise.This is a reportable event based on delay in reporting of patient results for class a analyte.

• Brand Name: AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900
• 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: 13006791
• MDR Text Key: 289746828
• Report Number: 3004529019-2021-00080
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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: 12/15/2021

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-900
• Device Catalogue Number: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1