MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Calibration Problem (2890)

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

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) followed up with customer over the phone.While troubleshooting with customer, fse noted that customer replaced the column but didn't prime well.Fse instructed customer to run 10 samples.All samples completed without errors.No further action required by field service.The g8 instrument is functioning as expected.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4).There were two (2) similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 1, introduction and applications, states the following: the time from injection of the sample to the time the specific peak elutes off the column is called retention time.The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times.If the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results.If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate.1.4 storage and stability the unopened tskgel g8 variant hsi column should be stored at 4-15°c in a cool location away from direct sunlight.The column is stable until the expiration date printed on the label.Columns are warranted for 2500 injections.In chapter 5: maintenance procedures, section 5.6 provides detail information on how to replace the column.In chapter 6: troubleshooting states the following 201 calib error is generated when the assay results for the calibrators were unsatisfactory.Check the dilution method, and the column and filters.Verify that the reagents have not expired.Do the values for calib-1 and calib-2 in the parameter screen agree with the assigned values (refer to the instructions for use or the label of the calibrator) 211 peak pattern error is generated when peaks were not separated well operator is instructed to check the samples, buffers, and hemolysis & wash solution.6.4 abnormal chromatograms although the percentage of each hemoglobin component may vary slightly from patient to patient, most whole blood samples will contain six fractions: a1a, a1b, f, la1c+, sa1c, and a0.Chromatograms from patients with hemoglobin variants or unknown peaks not recognized by the analyzer are occasionally seen during routine testing.These patterns may indicate interferences or problems with the assay.Therefore, it is important to use caution when troubleshooting.Review all chromatograms to determine whether the results are valid.In most cases, results for the sa1c% are reportable.In some cases, the sa1c% may be invalid depending on the hemoglobinopathy present, the flow rate, and the condition of the column and reagent system.Remember that all abnormal chromatograms are not necessarily the result of abnormalities in the patient sample.Analyzer problems such as a malfunctioning pump or sampling unit, a column that should be replaced or reagents that are incorrectly placed or have been depleted can also cause abnormal chromatograms.In these cases, sequential chromatograms are usually all affected from the point that the problem began.The most probable cause of the reported event due to operator error: inadequate priming after replacing the column.

Event Description

A customer reported getting 201 calibration error on the g8 instrument.The customer stated they are running n lot.Customer replaced all the buffers and performed multiple drain flush procedure.Pressure is 8.87 and instrument has a new column, new filter and retention time (rt) was 0.60 minutes (acceptable range is 0.57 to 0.61 minutes).Technical support specialist (tss) instructed the customer to run five whole blood samples.Customer states there are multiple p00 peaks, hb variant, and check peaks flags.All five samples had these errors.Tss will send a replacement column and instructed the customer to perform more drain flushes and run multiple whole blood samples to try to resolve the flags.The customer received the new column, installed it and calibrated; calibration passed but check peaks, multiple p00 peaks, hb variant peaks and peak pattern error 211 persisted on controls and whole blood samples.A field service engineer (fse) was dispatched to address the reported event, which could have resulted in delay of results for hemoglobin a1c (hba1c).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 8187176
• MDR Text Key: 132055669
• Report Number: 8031673-2018-05328
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2018
• Distributor Facility Aware Date: 11/21/2018
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/20/2018
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2010
• 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