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

Model Number G8

Device Problems Imprecision (1307); Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.Upon arrival fse confirmed the errors.Then fse performed annual periodic maintenance (pm).Proper device operation was determined by running calibration, precision and quality controls (qc) without errors.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 was one similar complaint identified during the search period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: 1.8 limitations of the procedure: 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.The g8 variant analysis mode training manual version 1.8, method validation for your hplc analyzer, states the following: method validation studies confirm a manufacturer's claims for an analyte and are usually performed upon installation of a new analyzer.They may also be performed when a new test is added to an existing system or as required by a regulatory agency.1.Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: a.Accuracy b.Precision c.Reportable range of test results for the test system.2.Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population.The four performance tests listed above are required for clia compliance.Each laboratory should establish protocols and procedures in accordance with performance criteria appropriate for the patient population being tested and interpretation of regulations under which the laboratory operates.Complete details of clia guidelines can be found at www.Phppo.Cdc.Gov/clia/regs/toc.Aspx.Precision is the reproducibility of an assay and is measured by running a specimen multiple times.Precision can be checked at a single level or across several levels.A tosoh bioscience representative will perform a 20-point within run precision study during instrument installation to validate the performance of the analyzer unless the laboratory provides their own internal protocol.The specimens used to determine assay precision must be similar to routine patient specimens.To verify the manufacturer's claim, specimens should have values that are within the stated linear range on the analyte specification sheet.Coefficient of variation is calculated using the following equation: cv = (sd) (100) ÷ mean.Reportable range studies are required by clia regulations to substantiate the accuracy of the assay throughout the laboratory's reportable range.This study requires analysis of at least two replicates of three concentrations throughout the reportable range.Each laboratory should establish protocols and procedures in accordance with performance criteria appropriate for the patient population being tested and interpretation of regulations under which the laboratory operates.Please refer to clia regulations "appendix c: survey procedures and interpretive guidelines for laboratories and laboratory services, subpart k, part 1, d5439" for further information.The most probable cause of the reported event remains unknown as the issue resolved with pm.It may possibly be related to the internal tubing.

Event Description

It was reported that the customer experienced low total area, check peak flags, and poor precision while performing hplc linearity with their g8 analyzer.When the customer performed calibration the first result for calibration 1 had a total area (ta) of 264, while the rest had total areas of 812.Technical support (ts) instructed the customer to run a precision study on whole blood, which yielded hemoglobin a1c (hba1c) results of 3.8%, n=15, and all the ta's approximately 870.The customer reported that no patient samples were being run due to poor imprecision on a patient sample that obtained hba1c results of 7.1%, 8.1%, 8.5%, 8.6%, and 8.7%.There is no indication of any patient intervention or adverse health consequences due to this event.A field service engineer was dispatched to further investigate the reported issue.There was 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 10586 23; JA 1058623
• 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, CA 94080 ; 6506368123
• MDR Report Key: 7545232
• MDR Text Key: 109768530
• Report Number: 8031673-2018-00483
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2018
• Distributor Facility Aware Date: 05/08/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/25/2018
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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