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

Model Number AIA-900

Device Problems Fracture (1260); Failure to Align (2522)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and reproduced error by performing a prime wash and observed the bf1 probe hitting the side of the wash priming well due to failure of alignment which generated error 4313.The bf1 probe tip was fractured from hitting the priming well which generated error 2239.Fse performed pm on analyzer, realigned bf1 to the priming well and replaced the wash probe tip.Fse completed quality control without any errors and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.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: [2239] bf probe 1 purge failure.Cause: the overflow sensor (b)(4) failed to detect liquid after the washer was discharged.Action: it is conceivable that air has entered the washer tube.Prime the tube and bleed off the air.Check the remaining quality of washer, check to see if there is air in the washer tube, and check (b)(4), the discharge solenoid valve (b)(4), and the washer tube.[4313] wash1-z home overrun.Cause: the home sensor (b)(4), which is not supposed to be activated after the bf probe 1 moves, was activated.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check (b)(4) and also check to see the cause of slipping, and so on, that occurs when (b)(4) moves to the limit side.The most probable cause of the reported event is due to misaligned bf1 probe & failure of bf1 probe tip.

Event Description

A customer reported getting error messages "4313 wash1-z home overrun" and "2239 bf probe 1 purge failure" on the aia-900 analyzer.The customer confirmed proper bf probe connection and tip installation.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 intact parathyroid hormone (ipth).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: 12678116
• MDR Text Key: 277885855
• Report Number: 3004529019-2021-00056
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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