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

Model Number AIA-900

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/24/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) followed up with the customer over the phone to resolve reported event.Customer confirmed and reproduced reported error.While troubleshooting with the customer, the seal breaker assembly/finger screw was found loose causing seal on cup not to break causing error 2160.The customer was instructed to tightened seal breaker assembly/finger screw to correct and prevent further errors.The customer confirmed the aia-900 analyzer is operating as expected by running samples without error.No further action required by field service.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: [2160] c.Transfer not detected cup cause: the cup sensor s063 failed to detect the cup before it was grasped.Action: please contact the tosoh local representatives.Check s063, the cup pickup position, and the cup pickup operation.The most probable cause of the reported event is due to loose seal breaker finger screw.

Event Description

A customer reported getting error message "2160 c transfer not detected cup" on the aia-900 analyzer.The customer rebooted analyzer but error persisted.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), follicle stimulating hormone (fsh), luteinizing hormone (lhii) and estradiol (e2).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: 12308549
• MDR Text Key: 266075105
• Report Number: 3004529019-2021-00006
• 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
• Type of Report: Initial
• Report Date: 08/11/2021

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
• Initial Date Manufacturer Received: 07/24/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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