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 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field service engineering (fse) visited the customer to address the reported event.During servicing, fse found the mix well dry with dried blood in it.Fse powered the instrument down.When the instrument was repowered, fse found that buffers #2 and #3 were almost completely empty and the tubing was not in the bottom of the buffer bags.Fse replaced the buffer #2 and #3 and the hemolysis wash and then performed a complete start up.All fluids were flowing in the system.Fse ran several random samples to check the chromatograms and did not get any missing peaks.The customer made quality controls and calibrators and calibration was performed with acceptable results.A 10 point precision was performed on a normal patient sample and had acceptable results.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) and calibrator lot zs7001 from 05-sept-2017 through aware date 05-oct-2018 and there were 3 total complaints, including this complaint, related to the reported event during the searched period.The g8 operator's manual under chapter 1, introductions and applications, states the following: quality control in order to monitor 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.Qc materials should be used in accordance with local, state, federal and accredited organizations.Controls should be diluted with hsi hemolysis & wash installing g8 variant elution buffer his for each reagent, remove the cap, carefully squeeze the buffer bag by hand to minimize air pockets, and then place the appropriate color-coded tubing into the corresponding bag.Ensure that the end of the tubing is touching the bottom of the container.The most probable cause of the reported event was the buffers were almost empty and the buffer lines were not down in bottom of the bags.

Event Description

A customer reported that the instrument failed calibration after replacing a column with the g8 instrument.The customer reported that they were using calibrator lot zs7001 and confirmed that the column and half-full buffers were both from matching lots.The customer had already changed the filter.The retention time was 0.61 minutes and there were no leaks at the column or filter when pumping buffer and observing for leaks.The customer reported that there were no total areas and technical support (ts) advised the customer to change the sample needle.Upon follow up, the customer reported that there were still no results after changing the sample probe.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 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: 7993809
• MDR Text Key: 126249115
• Report Number: 8031673-2018-00961
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• 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: 10/22/2018
• Distributor Facility Aware Date: 10/05/2018
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/22/2018
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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