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

Model Number AIA-900

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of error 2239 on the aia-900 analyzer.The device was being used for diagnosis during the complaint event.At the customer site, a field service engineer (fse) found a line coming from the wash tank was not connected.The disconnected line was due to a component failure.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A 13-month complaint and service history review for serial number (b)(4) from date of 15aug2020 through aware date 15sep2021 was performed for similar complaints.There were no similar complaints identified during the search period.The aia-900 operator¿s manual under section 12 flags and error messages states the following: error message: [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.

Event Description

Customer reported an error 2239 - bf probe error.The tips are on and the wash wells are not full.There were no leaks observed.A wash prime was performed and resulted in an error.This is a reportable event based on delay of reporting patient results for estradiol (e2) assay.

• Brand Name: AUTOMATED ENZYME IMMUNOASSAY ANALYZER 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: 12611611
• MDR Text Key: 276459131
• Report Number: 3004529019-2021-00043
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1