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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer (fse) followed up with customer over the phone.Customer informed fse that they replaced the sample needle and the instrument is working fine, thought they got an x axis error due to technician moving rack while instrument was running.Customer states error cleared and the g8 instrument is functioning as expected.No further action was required by the fse.A (b)(4) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were two (2) similar complaints identified during the searched period, which includes this event.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 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.The 706 syringe-l error: is generated when there is an operation error in syringe-l.Operator is instructed to inspect syringe-l and execute smp.Reset.The 708 x1- axis error: is generated when there is an operation error in x1-axis.Operator is instructed to inspect x1-axis and execute sl.Rotate.The 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 g8 variant analysis mode operator's manual under chapter 5 - maintenance procedures; section 5.10: sampling needle replacement provides detailed information on how to maintain and replace a sample needle.The most probable cause of the reported event was due to bent sample needle.

Event Description

On (b)(6) 2018, a customer reported getting 710 z-axis error messages on the g8 instrument.Technical support specialist (tss) instructed customer over the phone to clean the guide rod of the sample nozzle.Customer stated the errors cleared and they were able to use the instrument, but the error reoccurred, as well as 706 l-syringe errors and pm flag.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, 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: 7470944
• MDR Text Key: 107211766
• Report Number: 8031673-2018-00356
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/27/2018
• Distributor Facility Aware Date: 03/30/2018
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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