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

Model Number G8

Device Problems Mechanical Problem (1384); Device Operational Issue (2914)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer (fse) was at customer's site to resolve reported issue.Fse inspected instrument and found faulty stator and rotor face seals.Fse replaced the stator and rotor face seals and verified that the three screws securing the injector valve face were tight.Fse successfully completed qc, ran patient precision run and all results were within acceptable range.The g8 instrument is working as expected without and leaks.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)(4) 2017 through aware date (b)(4) 2018.There were no similar complaints identified during the search period.The g8 variant analysis mode operator's manual under chapter 2, preinstallation, states the following: injection valve this valve is used to inject a sample into the assay line after sample dilution.In chapter 5: maintenance: section 5.2 daily checklist : operators are instructed to check the screw of the parts driving the valves, check/replace the valve stator face and check/replace the rotor seal of the injection valve, as part of a daily pre assay checklist.The most probable cause of the reported event was due loose screws on the face of the injector valve causing leakage.

Event Description

On (b)(6) 2018, a customer reported leaking from injection valve on the g8 instrument.Customer is unable to run patient samples, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).A field service engineer (fse) was dispatched to address the reported event.There is 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.The injector valve rotor/stator was returned for investigation on 30mar2018.Functional testing confirmed the part to be damaged.Part will be discarded.Device evaluation by manufacturer: the most probable cause of the reported event was due to failure of injector valve.

• 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
• MDR Report Key: 7442272
• MDR Text Key: 106299106
• Report Number: 8031673-2018-00317
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2018
• Distributor Facility Aware Date: 03/30/2018
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1