MAUDE Adverse Event Report: TOSOH CORPORATION G7

Model Number G7

Device Problems Device Ingredient or Reagent Problem (2910); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

On march 24, 2016, the field support engineer (fse) went to the customer site to evaluate and perform preventative maintenance on the g7 analyzer.Following, the preventive maintenance, the g7 analyzer operation was verified.Calibration was done using lot zs 4002 and the results were within range.In addition, the quality controls and precision testing performed were both in acceptable range.Based on the information available, the g7 analyzer cannot be ruled out as contributing to the reported malfunction.The potential cause of the qc unacceptable results received by the customer may be related to the need for replacement of wear parts such as o-rings, seals, tubing, filters and solutions as well as cleaning of the g7 analyzer.Review of the g7 variant operator's manual addresses calibration and quality controls: calibration procedure each laboratory must monitor qc results according to good laboratory practices to determine when to recalibrate.Calibration frequency should be based upon qc results and chromatogram quality.The analyzer has a two-point automatic calibration function.Studies have shown the calibration to be stable for at least seven days if the system is calibrated and maintained according to the procedures provided in this guide and the g7 variant analysis mode operator's manual.Verify that there is sufficient volume of elution buffers and hemolysis & wash solution.Replace if necessary.Check analyzer status.If analyzer is off, press the power key at bottom of display.The analyzer begins its 10.8 minute warm-up.If analyzer is in stand-by mode, proceed to step 3.Select calib from the main screen.Once selected, it will be reverse highlighted.Select menu, then parameter.Press calib-1 and enter the assigned value for calibrator 1 from the calibrator vial label.Press calib-2 and enter the assigned value for calibrator 2.Pipette at least 800 ¿l of each calibrator into sample cups.Place the sample cups in the rack with calibrator 1 in position 1 (on the left) and calibrator 2 next to it in position 2.Place an empty rack on the loader to signal the end of the run.Press the start key to begin the calibration.Any results for samples assayed after the calibration will be based on the new calibration curve.Calibration acceptability criteria : when the calibration procedure is completed, the analyzer automatically accepts or rejects the calibration results.If the calibration is unsuccessful, recalibration will be required.A calibration error message appears and the run aborts if: the two sa1c% results for calibrator 1 differ by 0.3% or more.The two sa1c% results for calibrator 2 differ by 0.3% or more.Any of the four calibrator results differs from its assigned value by ±30% or more.The analyzer samples calibrator 1 three times and calibrator 2 two times.The analyzer discards the first measurement of calibrator 1, and uses the remaining four measurements to calculate factors a and b.Following a successful calibration, patient and control samples will be calculated using the new factors.Tosoh recommends calibrating the analyzer once a week.The laboratory may establish a longer calibration interval based on daily qc results.Be sure to calibrate in the following situations: if drift in qc is noted the tosoh automated glycohemoglobin analyzer hlc-723g7 is a very precise instrument and you will note that the qc remains the same day after day.If there is a drift in qc values, it is necessary to recalibrate.When control values assayed are out of range, calibrate when the control assay value falls outside the qc range.Measure the control sample again to confirm that it falls within the qc range before assaying a patient sample.After column replacement calibrate after a new column has been installed.After analyzer maintenance calibrate after periodic maintenance or repair.When an assay condition is being modified calibrate when a parameter value (such as the flow factor) is being changed on the analyzer.Quality control : in order to monitor and evaluate the accuracy and precision of the analytical performance, tosoh recommends that commercially available control specimens be assayed daily and after column replacement.Tosoh suggests running at least two levels of quality control material.The mean of one should be in the non-diabetic range (4-7% hba1c) with the second in the range of 9-12% hba1c.If the value of one or more control specimens is out of the acceptable range, recalibrate the system and rerun the controls before testing patient samples.Follow standard quality control procedures in accordance with the strictest regulatory agency under which the laboratory operates.Controls should be diluted with hemolysis & wash solution to obtain a total area on the chromatogram in the range of 500-4500.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).

Event Description

On (b)(6) 2016, the customer reported that the quality controls (qc) are recovering higher with the g7 analyzer.The customer reported using supplier bio-rad controls.The customer noticed this shift with the last calibration, but does not know the lot number of the calibrators used and reported they do not have any more calibrators.Tosoh technical support specialist sent the customer calibrators with lot number zs 5001 and told the customer to repeat the calibration using this lot.The customer recalibrated using lot zs 5001 and the qc results were now out of range.The customer requested preventive maintenance service for the g7 analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: G7
• Type of Device: G7
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court, ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7336910
• MDR Text Key: 102725821
• Report Number: 8031673-2018-02219
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G7
• Device Catalogue Number: 019327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2018
• Distributor Facility Aware Date: 03/10/2016
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/13/2018
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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