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

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) device evaluation by manufacturer: a field service engineer (fse) was dispatched to the customer's site to address the reported event.Fse confirmed complaint by observing the flow rate set to 1.24.Fse replaced the check valve uptake.The customer successfully completed quality control (qc) run to validate instrument.No further action required by field service.The g8 instrument is functioning as expected.The check valve uptake was returned to tosoh instrument service center for investigation.Functional testing confirmed the reported fast retention time was due to partially occluded check valve uptake.A 13-month complaint history review and service history review for similar complaints was performed for the g8, serial number (b)(4) through aware date.There were no other similar complaints identified 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.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 fast retention time was due to the failure of the check valve uptake.

Event Description

A customer reported seeing fast sa1c retention time (rt) (acceptable range is 0.57 to 0.61 minutes) on patient samples with the g8 instrument.The technical support specialist (tss) advised the customer to adjust the flow factor from 1.18 ml/min to 1.21 ml/min in order to adjust the retention time to acceptable range of 0.57 to 0.61 minutes.Customer was also advised to power off and on instrument, then prime instrument with five samples run, calibrate and run quality controls (qc), then run patient samples.Customer followed up and stated, rt is still high on qc and p00 flag occurred.Tss advised the customer to adjust the flow factor again from 1.21 ml/min to 1.23 ml/min, then calibrate and run qc.The run completed with still fast rt at 0.62.Customer was advised to adjust the flow rate again, and the sa1c rt was 0.59 which is within acceptable range.The sa1c rt remained in range for several days, but customer later reported the sa1c rt is still drifting.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 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: 8341370
• MDR Text Key: 138252253
• Report Number: 8031673-2019-00024
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2019
• Distributor Facility Aware Date: 12/27/2018
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/14/2019
• Date Manufacturer Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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