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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: field service engineering visited the customer to address to address the reported event.Fse was able to confirm the error by running patient samples and getting the z-axis error.To troubleshoot, fse found the issue to be related to z-axis cable to sensors.Fse removed the sampling unit and replaced the z-axis cable to sensors.Fse then tightened z drive belt and performed cleaning and lubrication.Fse then placed a new sampling unit and ran 44 patients with no errors.The customer ran 80 patients without any errors.The instrument was verified as operational.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 (b)(6) 2017 through aware date (b)(6) 2018.There was one similar 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.

Event Description

A customer reported getting intermittent 710 z1-axis on the g8 instrument.The customer changed the sample needle and cleaned the guide rod, but the error continued.A service was performed on the instrument and field service engineering (fse) cleaned the guide rod but the error persisted.The customer tried new tracks but the error continued.The instrument was down.The 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.

Manufacturer Narrative

(b)(4), per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: the needle cable z-axis was received for evaluation on 19-jun-2018.Functional testing was performed finding that the cable and connector were good.The error could not be duplicated.The part passed testing.It is possible that the reported issue occurred due to bad connection from the cable interconnects.Evaluation codes: results: 213 no device problem found.Conclusion code: 67 no problem detected.The most probable cause of the reported event was likely a bad connection from the cable interconnects.

• 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
• MDR Report Key: 7649464
• MDR Text Key: 112871140
• Report Number: 8031673-2018-00596
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2018
• Distributor Facility Aware Date: 06/19/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/13/2018
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1