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

Model Number AIA-900

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

A customer reported an error message ¿2009 liquid leak¿ on the aia-900 analyzer.Technical support specialist (tss) instructed the customer to observe the well and found probe # 2 still had standing liquid in the well, no liquid in the tubing was noted and draining as expected.The tss also instructed the customer to empty the well and perform a wash prime, no visible liquid was noted.The customer also mentioned that probe #2 seemed stripped when they tried to tighten the screw, the customer attempted loading the sample, but the error persists.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), progesterone (prog iii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A field service engineering (fse) followed up with the customer over the phone to address the reported event.Fse confirmed the complaint with the customer and the customer attempted to reproduce the complaint, but the error did not recur.The fse instructed the customer to observe the wash probe tips that were attached to the bf probes and found wash in the bf probe well.In addition, fse instructed the customer to remove fluid with a transfer pipette, dried the sensor with a paper towel, and sprayed canned air onto the sensor.The customer primed the wash and performed sample runs without any errors.Fse could not determine the cause of the reported event, caused not established.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 10443710.There were no similar complaints identified during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states the following: (2009) liquid leak cause: leakage of solution was detected at the start of measurement, so measurement will stop.Action: please contact the tosoh local representatives.The most probable cause of the reported event is not determined, cause not established.

Manufacturer Narrative

Removing 10 (testing of actual/suspected device), should only have 4111 (communication/interviews) selected.

• 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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 18441513
• MDR Text Key: 331904971
• Report Number: 3004529019-2024-00488
• 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,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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