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

Model Number AIA-900

Device Problems Mechanical Problem (1384); Stretched (1601)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.The customer reported getting error 4271 and multiple other incubator errors.Fse confirmed the complaint by reviewing the error logs and reproduced error by performing a sample run.Fse visually inspected the incubator assembly and noticed that the carousel was slipping.Fse replaced the incubator assembly and performed bf wash position, sample dispense position and cup picking assembly alignments.Fse also performed daily check and quality control runs without any errors and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.The incubator assembly was returned to tosoh instrument service center for investigation.Visual and physical inspections of the part found a missing retainer ring in the cupholder and worn and stretched table drive belts.This indicates stress problems due to component failure.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-900 operator's manual under section 12: flags and error messages states the following: [4271] incubator home detect error: cause: the home sensor (b)(4) failed to be activated after the incubator moved toward the home position.Measurement will be interrupted.Action: please contact tosoh local representatives.(b)(4).The most probable cause of the reported event is due to failure of the incubator assembly caused by loose cupholder, worn and stretched table drive belt.

Event Description

A customer reported getting "4271 incubator home detect error" and other multiple incubator errors on the aia-900 analyzer.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for beta human chorionic gonadotropin (bhcg), estradiol (e2), follicle stimulating hormone (fsh) and luteinizing hormone (lhii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: 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: 12595409
• MDR Text Key: 276457355
• Report Number: 3004529019-2021-00040
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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