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

Model Number G8

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

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

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.Fse verified the shoulder peaks.Fse took the column tubing off and reseated the peek tubing in all the way to correct issue.Fse then ran precision and quality controls (qc) without any issues.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the installation date of 16-sept-2017 through aware date (b)(4) 2018.There were no similar complaints found during the searched period.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.Chapter 3 assay operations: chromatogram see the g8 variant analysis mode training manual for many examples of different chromatograms.The a1a, a1b and hbf may be eluted out with different peak shapes or not be detectable depending upon the sample.If you observe shoulders or splits around the sa1c or a0 peak, the assay condition may not be optimal.In addition, if the sample has been stored for a long time at room temperature after collection, an abnormal chromatogram may be obtained because the samples have deteriorated.If you observe the same phenomena with several different samples, the reagent may have deteriorated.Replace the elution buffers and run the assay again.If you observe an aberrant result with a single specific sample, the sample may have deteriorated or hemoglobin variants may be present.The tosoh automated glycohemoglobin analyzer hlc-723g8 variant analysis mode can separate the major variant hemoglobins (hbd, hbs and hbc).See "chapter 6 section 6.4: abnormal chromatograms" for typical chromatograms.But some hemoglobin variants such as hbe can not be separated and it may interfere with the assay.The chromatogram pattern for hemoglobin variants differs from that of a normal sample.The g8 variant operator's manual under chapter 5, maintenance procedures states the following: 5.6 column replacement replace the column in the following situations.When the pressure is more than what is indicated on the column inspection report + 4 mpa and is not reduced by filter replacement.When peaks on the chromatogram (particularly the shaded sa1c peak) have become broad or broken into two fractions.Caution: if this phenomenon is observed only with a specific sample, column deterioration may not be the cause.Other factors, such as a hemoglobin variant, could be the cause.When assay results for quality control samples are consistently out of the assigned ranges even after re-calibration.When the calib error persistently occurs.Please contact technical support if the above issues are not resolved after column replacement.The g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause of the errors was the column peek tubing was not seated properly by the customer.

Event Description

A customer reported getting shoulders on the a0 peak with the g8 instrument.The customer reported that the column count was 1209 injections and the flow rate was 1.05 ml/min.Patient retention times were running at 0.61-0.62 minutes.Technical support (ts) instructed the customer to change the flow rate to 1.08 ml/min, reboot the analyzer, and perform calibration.However, the issue persisted.The customer sent the data to ts for review who found a shoulder before and after a0 peaks on all patients, quality controls (qc), and calibrators.Ts suggested the customer change the column but the customer declined.The instrument was down.Field service engineering was dispatched to address the reported, which resulted in delay of reporting hga1c patient results.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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 8022421
• MDR Text Key: 125640808
• Report Number: 8031673-2018-00993
• 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: 10/30/2018

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: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2018
• Distributor Facility Aware Date: 10/16/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/30/2018
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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