MAUDE Adverse Event Report: TOSOH HI-TEC, INC. 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 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint/service history review: a 13-month complaint history review and service history review for similar complaints was performed for instrument serial number (b)(4).No other similar complaints were identified during the search period.Review of related documentation: the aia-900 operator¿s manual states the following: [4034] sorter-x limit overrun.Cause: a shift instruction or adjustment value corresponding to a distance exceeding the distance over which the sorter x-axis can move was assigned.A retry will take place, and if there is no improvement an mf flag will be attached to the measurement result.Action: please contact tosh local representatives.Take care not to assign a shift instruction exceeding the distance over which the x-axis can move.An investigation was performed in response to a complaint of error [4034] sorter-x limit overrun on the aia-900 analyzer.The device was being used for diagnosis during the complaint event.At the customer site, field service observed a deviation while running the sorter test and performed a dispense lane alignment which resolved the reported error.This indicates failure to align due to component failure.In conclusion, this investigation confirmed a failure of the aia-900 analyzer to meet specifications or intended use.The test cup lane assembly exhibited failure to align due to component failure.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.

Event Description

The customer reported receiving error [4034] sorter-x limit overrun on the aia-900 analyzer while running quality control.During troubleshooting, the customer discovered dropped cups and removed them.When the customer attempted to run the analyzer, the error came up.The customer then rebooted the analyzer and attempted to run again but the error occurred.Technical support then had the customer check for any dropped cups or tips near the incubator or top of the waste chute but none were observed.Field service was notified.A field service engineer (fse) was dispatched to address the reported issue.There was a delay in reporting beta-human chorionic gonadotropin (bhcg), estradiol (e2), luteinizing hormone ii (lh ii), and follicle-stimulating hormone (fsh) patient results.However, there was no patient intervention or adverse health consequences due to the event.

• 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: 12346133
• MDR Text Key: 269274524
• Report Number: 3004529019-2021-00012
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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