MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineer (fse) was at the customer's site to address the reported event.Fse confirmed the problem by reviewing the error log and reproduced the problem by performing qc run.Fse found that the detector lens was dirty and cleaned the lens, which solved the high qc.Fse validated the instrument by running customer prepared qc; qc passed and within acceptable range.Fse successfully calibrated, performed precision and control runs without error and within acceptable range.No further action required by field service.The aia-900 instrument 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 st aia-pack follicle stimulating hormone (fsh) analyte application manual states the following: evaluation of results: 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 detector lens.

Event Description

A customer reported out of range high quality control results for follicle stimulating hormone (fsh) on the aia-900 instrument.The technical support specialist (tss), sent mac controls, new calibrator and a substrate bottle to customer for further investigation.Customer received reagents and reported mac control run for fsh resulted in out of range low results.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of follicle stimulating hormone (fsh) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

Corrected data: unchecked incorrect entry in section b2.

Event Description

N/a.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 10007932
• MDR Text Key: 192638152
• Report Number: 8031673-2020-00123
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: 022930111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention