MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

A customer reported american proficiency institute (api) failure for thyroid stimulating hormone (tsh) on the aia-360 analyzer.Using tsh test cup lot d117250, customer's api failed on sample numbers 13, result was 7.64 iu/ml, with an expected result range of 5.18-7.47 iu/ml and sample number 15, result was 5.64 iu/ml with an expected result range of 3.60-5.38 iu/ml.Tosoh api results passed for all samples.The customer confirmed samples were properly stored and handled.The customer also confirmed no issues with calibrations; however, the trending quality control (qc) data has been high.The customer performed a decontamination three weeks prior to the failing api results.Customer has ceased testing for tsh.A field service engineer (fse) has been dispatched to address the reportable event.There was no indication of any patient intervention or adverse health consequences.

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem by reviewing the quality control (qc) data.The fse replaced the sample nozzle and performed a decontamination on the analyzer.The fse instructed the customer to run qc and results were within acceptable range.Tsh cup lot d417264 was performed without errors.The aia-360 analyzer is functioning as expected.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)(6).There were no similar complaints identified during the search period.The st thyroid stimulating hormone, analyte application manual states the following: quality control in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: ¿ after calibration, two levels of controls are run in order to accept the calibration curve.¿ the two levels of controls are also repeated after calibration when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).¿ after daily maintenance, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.The most probable cause of the reported event was due to failure of the sample nozzle and biological contamination of the analyzer.

• Brand Name: AIA-360
• 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: 18167365
• MDR Text Key: 328970630
• Report Number: 3004529019-2023-00456
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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