MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA 2000

Model Number AIA 2000

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

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

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: 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.A 13-month lot review for bhcg calibrator lot jx33532 was performed through aware date of event.There were no other similar complaints found during the searched period.The st aia-pack beta human chorionic gonadotropin (bchg) 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.Limitations of the procedure: for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).Using st aia-pack bhcg, the highest concentration of total beta hcg measurable without dilution is 400 miu/ml, and the lowest measurable concentration is 0.5 miu/ml (assay sensitivity).Although the approximate value of the highest calibrator is 200 miu/ml, the exact concentration may be slightly different.The assay specification, assay range high, should be defined as the upper limit of the assay range, 400 miu/ml.Although hemolysis has an insignificant effect on the assay, hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution.The most probable cause of the reported event was due to normal lot to lot variability.

Event Description

A customer reported out of range quality control results for beta human chorionic gonadotropin (bhcg) after calibration with new calibrator lot jx33532 on the aia-2000 instrument.Technical support specialist (tss) sent new calibrator lot to the customer.The customer recalibrated and completed quality control without errors and results are now in range.No further action required by tss.The aia-2000 instrument is functioning as expected.There was no indication of patient intervention or adverse health consequences due to delay in reporting beta human chorionic gonadotropin patient samples.

• Brand Name: AIA 2000
• Type of Device: AIA 2000
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer Contact: bernadette oconnell ; 6000 shoreline court; suite 101; south san francisco, ca ; 9368143
• MDR Report Key: 10174909
• MDR Text Key: 202409765
• Report Number: 3005529799-2020-00041
• Device Sequence Number: 1
• Product Code: KHO
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA 2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2015
• 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