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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 26-mar-2018, field service engineer (fse) was dispatched to the customer's facility to address the reported event and conduct a preventive maintenance (pm) on the g8 instrument.Fse was not able to duplicate the customer's reported issue with low qc recovery using tosoh calibration set points and tosoh hemoglobin a1c controls material.The instrument is noted to be due for a pm, as it was observed that the previous maintenance was performed last year, on (b)(46 2017.Fse performed pm on the instrument, ran calibration, qc, and precision; all results were within specifications.The qc result was at the tosoh mean, level 1 at 5.5% (level 1: the mean is 5.5%, range is 4.9% - 6.0%) and level 2 at 11.0% (level 2: the mean is 11%, range is 9.9% - 12.1%).The g8 instrument is functioning as intended.No further action required by field service.A (b)(4) complaint history review and service history review for similar complaints was performed for the g8, serial number (b)(4) and tosoh qc lot # 7055 , from (b)(6) 2017 to aware date (b)(6) 2018.There were no other similar complaints identified during the searched period.The g8 operator's manual under chapter 1, introduction and applications, states: when there is a question concerning the chromatography, repeat the sample.If the repeated sample also displays unusual characteristics, it is appropriate to evaluate whether the unusual result is due to an abnormal sample, a procedural error, an instrument malfunction or a sample-handling problem.For further information, see the troubleshooting section in this operator's manual.Quality control in order to monito:r and evaluate the accuracy and precision of the analytical performance, controls should 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.Chapter 5 in the operator's manual provides guidance on instrument maintenance, including column replacement, daily and maintenance log.The most probable cause of the reported event could not be determined.Field service performed preventive maintenance and the qc results were within expected range and the instrument is functioning as intended.

Event Description

On (b)(6) 2018, a customer reported getting low quality control (qc) result with the tosoh qc on the g8 instrument.Customer reported the instrument was recalibrated, but did not resolve the issue.Customer stated the column was recently changed, and the column count at 100, filter count at 120, the pump pressure at 7.6 mpa.Technical support specialist (tss) reviewed chromatogram data received from the customer.Tss confirmed the low qc results and patient samples at 12.5% and post-calibration with the new column, the patient sample at 12.3%.Tss also noted that the customer's g8 instrument is due for a preventive maintenance (pm).Customer requested a pm service.On 26-mar-2018, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was 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
• 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; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7449586
• MDR Text Key: 106859896
• Report Number: 8031673-2018-00330
• 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: 04/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2018
• 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: 04/21/2018
• Distributor Facility Aware Date: 03/22/2018
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/21/2018
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• 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