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

Model Number AIA-900

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

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the results of the laboratory information system (lis) and ran controls.While troubleshooting, fse found the detector lens was slightly soiled and the probe tips were slightly worn, the z-axis and temperature were all within specifications.In addition, fse cleaned the detector lens, checked the z-axis cup at the bottom on the incubator and d lane.In addition, fse replaced the wash probe tips, flushed the specimen nozzle, ran fsh controls and were within range, but prog iii was continuously out of range.Fse ordered a different batch of prog iii test cups for the customer to rerun.The customer used the new batch of prog iii test cups to run qc and all were within range.Fse repaired and validated the analyzer and 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 10714507.There were no similar complaints identified during the searched period.A 13-month lot review for biorad qc lot# 40423 and prog iii test cup lot # d51c385 through the aware date 16oct2023 was performed for similar complaints.There were no similar complaints identified during the search period.The st fsh 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 st progiii 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 shall be assayed according to the local regulations.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of the internal control are run in order to accept the calibration curve.The two levels of controls are also repeated 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 shall be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control value(s) is out of the acceptable range, it is necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the strict regulatory agency under which the laboratory operates.The most probable cause of the reported high fsh was due to worn probe tips and dirty detector lens; high progiii cause could not established.

Event Description

A customer reported intermittent biorad quality control (qc) lot # 40423 out of range high result for follicle stimulating hormone (fsh) and prog iii (progesterone) on the aia-900 analyzer.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 follicle stimulating hormone (fsh) and prog iii (progesterone).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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 18117414
• MDR Text Key: 327880860
• Report Number: 3004529019-2023-00454
• 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: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• 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: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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