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

Model Number G8

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(4) 2018, fse arrived at the site to address the reported event.Inspection of the device confirmed the customer's report of low total areas.Additionally, fse found that the customer was also receiving large syringe errors.Fse replaced the large syringe to resolve the large syringe errors and reattached/ tightened the peek tubing to either side of the column to resolve the low total area.Fse was subsequently able to run patient samples and quality control (qc) without issue.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 04apr2017 through (b)(4) 2018 there were two similar complaints identified.The g8 variant analysis mode operator's manual under chapter 1, introduction & applications, and chapter 6, troubleshooting, state the following: total area: dilution studies demonstrate that the assay is linear from a total area of 500 to 4000.However, the optimum total area is 700 to 3000.Interpretation of results: results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see "abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.General 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.With these errors, the assay stops and the analyzer immediately enters stand-by state.The 706 syringe-l error explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.The most probable cause of the reported event was due to operator error (improperly attaching peek tubing to the column) and failure of the large syringe.

Event Description

On (b)(6) 2018, the customer reported low total area on all samples with their g8 analyzer.Inspection of the waste lines did not reveal any obstructions and the hemolysis wash was confirmed to be full.Technical support (ts) instructed the customer to change the sample needle assembly; however, the error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Results code: 213; no failure detected.Conclusion code: 67; unable to confirm complaint.Device evaluation the large syringe was returned to instrument service center (isc) for evaluation with no shipping damage.Functional testing of the returned large syringe passed.The reported event could not be duplicated.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• 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: 7525196
• MDR Text Key: 108751997
• Report Number: 8031673-2018-00467
• 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: 06/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2018
• Distributor Facility Aware Date: 05/04/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/23/2018
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1