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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 26-mar-2018, a field service engineer (fse) followed up over-the-phone with the customer and the customer informed fse that the sample needle was replaced, and confirmed the g8 instrument was performing within specifications.No further action was required by the fse.A 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 were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: the 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.In chapter 3 - assay operations, suggests to check the flow line connections, particularly the filter and the column inlet and outlet for leaks during warming up operations.Tighten the connection if a leak is found.In chapter 6 - troubleshooting states, the 100 pressure high is generated when the pump pressure exceeded the upper limit (15 mpa) set in the pres high parameters.Also when the filter or column replacement period has been exceeded, first replace the filter or column.If the pressure is still high, remove the inlet and outlet flow line around the column and filter, and determine which part is the cause of the high pressure.Then, contact a technical support representative.If the pressure displayed on the screen is: (a) greater than the pressure on the column inspection report + 4 mpa, then replace the filter.(b) less than the pressure on the column inspection report, then proceed with priming the column.The 200 area low error is generated when three successive results below the lower limit of the total area (50) occur.If the error message is present when sufficient volume of sample is set in the rack, the problem may be caused by an empty reagent (hemolysis & wash solution).Operator is instructed to check the remaining volume of hemolysis & wash solution and start the assay again.The most probable cause of the reported issue was due to sampling issue.

Event Description

On (b)(6) 2018, a customer reported getting 100 high pressure error message on the g8 instrument.The customer changed the filter and error cleared.The customer then ran quality control (qc) and her total areas were low.L1 = ta 44; l2 = ta 580 (acceptable ta range is 500-4000).The customer attempted repeating the same sample cups but got low and high total area results.Technical support specialist (tss) instructed customer to prepare a fresh qc with 20ul of control material; the following qc run resulted in qc l1 = ta 1903, sa1c rt = 0.62; qc l2 = ta 1207, sa1c rt = 0.60.(rt acceptable range 0.57 - 0.61 minutes).Tss suggested customer change the sample needle and call back.On 23-mar-2018, customer called back to report low total areas on all samples including controls and patient samples in edta tubes.Tss instructed customer to check waste line for any kink or obstruction.The customer was also instructed to check wash and hemolysis levels and all tubing.Tss recommended to customer to change the sample needle and run a mixed rack of specimens that consist of whole blood and qc dilutions.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of hba1c patient results.There is no indication of any patient intervention or adverse health consequences due to this 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7449326
• MDR Text Key: 106859496
• Report Number: 8031673-2018-00323
• 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: 04/20/2018

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Distributor Facility Aware Date: 03/22/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/20/2018
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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