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

Model Number G8

Device Problems Device Maintenance Issue (1379); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) went to the customer site to evaluate the problem and found the instrument getting solid x1 errors and the sample loader in dire need of cleaning and lubrication.The fse indicated per printouts, instrument ran out of buffer and was getting rt/peak errors.The fse checked all three (3) buffer valves and found no problem.Customer cleaned sample needle and found it very worn so it was replaced.Printouts show missing print of numbers and letters so the thermal printer was replaced.The fse returned the flow rate back to time of last preventive maintenance and the rt now at 0.62.The customer placed the flow rate at 1.00 and will recalibrate in the morning.The most probable cause of the reported problem is related to operational error.The g8 service, operator's, and training manuals were reviewed and found to clearly address calibration, quality controls, operation, maintenance, error codes, and troubleshooting pertaining to the g8 system.The g8 training manual provides the following information: the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode uses nonporous ion-exchange high performance liquid chromatography (hplc) for rapid, accurate, and precise separation of hba1c from other hemoglobin fractions.Separation is achieved by utilizing differences in ionic interactions between the cation exchange group on the column resin surface and the hemoglobin components in a step gradient elution.The hemoglobin fractions (designated as a1a, a1b, f, la1c+, sa1c, a0, and h-v0, h-v1, h-v2) are subsequently removed from the column material by performing a step-wise elution using elution buffers hsi variant 1, 2, and 3 that have specific salt and ph concentrations.The time it takes from injection of the sample to the time the specific peak elutes off the column is called the retention time.Each of the expected fractions has a window of acceptable retention times.As long as 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 the specified window, an unknown peak (p00) results.Each peak that elutes at a retention time that does not fall within the specified window 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 flow factor.It is very important that the operator review the chromatograms before reporting results.Chromatograms should contain six peaks and have sharp la1c and sa1c peaks.Mathematical algorithms used in the software exclude variant peaks eluting after the a0 peak when calculating the total area.The sa1c% is usually not affected in such situations, although chromatograms should be carefully reviewed.Hbs, hbd and hbc elute after the a0 peak.The sa1c% is generally reportable on the g8 when these hemoglobins are present in the heterozygous state with hba.Hplc methodology necessitates a review of a 'run' of samples that have been run sequentially rather than just one sample.Question any chromatogram with the following characteristics (see examples below): the total area reported is less than 500 or greater than 4000.The sa1c value is below the normal range established by your laboratory.An unidentifiable peak (p00, p01, etc.) appears before the a0 peak.If a result displays any of these characteristics, repeat the sample.If the repeated sample also displays unusual characteristics, then it is appropriate to determine whether the "problem" affects just that one sample or the whole run.This can determine whether the problem is sample or instrument dependent: columns are warranted for 2500 injections.Change filter after 400 injections.Ideal retention time for sa1c is ~0.59.Change flow factor to adjust rate.After opening, elution buffers (800 ml bags) are stable 3 months on the system.The total area is the sum of the surface areas under the peaks and must be between 500 - 4000.The optimum range is 700 - 3000.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.Poor peak identification.Cause: buffer deterioration.Resolution: check buffer expiration date.Do not pool buffer bags even if they are the same lot.Change buffer.Cause: buffer lot mistake.Resolution: make sure buffer lot matches column lot.Make sure the buffer tubing is installed in the correct buffer bag.Cause: column deterioration.Resolution: change the column.Make sure fittings are well seated.Error code 140 (buffer empty) the remaining reagent is low.A message will be displayed only if the alarm is set.(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 called tosoh technical support (tts) to report hemoglobin fractions sa1c, la1c and a1a were not detected, and also indicated that the total area was too low.The customer further reported: column count 7000, filter count 232, flow factor 0.98 and retention time 0.51.The customer replaced the column and following, total area 2000-2400, expanded peaks and saic was 27%, 30%.The customer now reported receiving an error code 140 (buffer empty) but reports that the buffers are full.The customer adjusted the flow rate which had no effect on the retention time.The customer indicated no leak was found, the retention time remains 0.55 and there are still no peaks.The customer was advised not to use the g8 analyzer due to multiple errors.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of patient results for hba1c.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: 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 (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: 7372393
• MDR Text Key: 103812139
• Report Number: 8031673-2018-02234
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2018
• Distributor Facility Aware Date: 06/17/2016
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/26/2018
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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