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

Model Number G8

Device Problems Mechanical Problem (1384); Decrease in Pressure (1490)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) contacted the customer over-the-phone to address the reported event.Fse was able to troubleshoot the instrument so that the customer was able to run.Fse then went onsite to perform service.During servicing, fse was unable to duplicate the errors as the customer had already cleaned the sample needle guide rail to allow smooth z-movement during troubleshooting.Fse then recleaned and lubricated the guiderails.Fse removed the needle and found the tip slightly bent, straightened and ordered a replacement.Fse remove two rubber o-rings at the base of the needle and cleaned the area.Fse also adjusted x and y alignments for the sample loader to the center of the patient tube.Fse performed general cleaning of the analyzer and found no further issues or concerns.The customer noted that the drain bottle never needed to be emptied.Fse then cleaned the wash well and verified good flow of waste into waste bottle.The customer ran quality controls (qc) and several patient samples without any errors.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 13-nov-2017 through aware date (b)(6) 2018.There were no similar complaints including this complaint identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting states the following: 6.3 error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.710 z1-axis error: an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The most probable cause of the reported event was due to the x and y axis were out of alignment.

Event Description

A customer reported getting 710 z1-axis error messages while running patient samples on the g8 instrument.The instrument was down.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 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: 8209432
• MDR Text Key: 132542802
• Report Number: 8031673-2018-05387
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2019
• Distributor Facility Aware Date: 12/13/2018
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2019
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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