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

Model Number G8

Device Problems Fluid/Blood Leak (1250); Decrease in Pressure (1490)

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

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.Fse confirmed the complaint by watching device pressure drop intermittently, producing the "101 pressure low" error.Further inspection of the device revealed that the waste overflow was due to the waste tank spout being placed inside the tank instead of outside preventing waste line ventilation.Fse repositioned the tank spout outside of the tank with the hose in the spout to allow for better drainage.Fse replaced the 2-way solenoid valves, the column due to high injection count, calibrated, and ran quality control (qc).A patient sample was used to validate the repair.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 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.101 pressure low: the pressure will not rise because the pump is unable to run due to air bubbles in the pump check valve.If the elution buffer is empty, place a new elution buffer and execute reagent change.Next, execute drain flush.See "chapter 5 section 5.5: pump air removal".Execute manual pumping using the pump key in the main screen (second screen), and open and close the drain valve 2 or 3 times.If the pressure rises when the drain valve is closed, the operation is complete.If the pressure still does not rise or stabilize, execute drain flush again.In addition, confirm that the drain valve is securely closed.The most probable cause of the reported event was due to failure of the 2-way solenoid valve.

Event Description

It was reported that the customer experienced low pressure, "101 pressure low" error, and leakage with their g8 analyzer.The customer stated that the leak appeared to be coming from the waste port at the bottom of the device.The customer requested service.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.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, 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.

Manufacturer Narrative

Please note that this mdr mfr report #: 8031673-2018-00875 / importer report #: (b)(4) was previously submitted to the fda on 22nov2018; it was recreated as mfr report #: 8031673-2018-00875 per request by the fda mdr data systems team representative.One 2-way solenoid valve was returned for evaluation to tosoh instrument service center (isc) with no shipping damage.Functional testing of the substrate syringe failed.The 2-way solenoid valve failed testing.The reported event was duplicated, which confirmed the reported event was due to failure of the 2-way solenoid valve.The most probable cause of the reported event is due to failure of the 2-way solenoid valve.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, 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.Incorrect numbering mdr# 8031673-2018-00956 /importer report #: (b)(4) was corrected to mfr report #: 8031673-2018-00875.

• 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 105-8 623; JA 105-8623
• 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,
• MDR Report Key: 7886883
• MDR Text Key: 123723172
• Report Number: 8031673-2018-00875
• 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,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2018
• Distributor Facility Aware Date: 08/22/2018
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/04/2018
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• 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