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

Model Number G8

Device Problem Device Operational Issue (2914)

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.Fse replaced the sample needle assembly and adjusted the flow rate & sample uptake.Additionally, fse checked the injection valve seal and stator, performed a drain flush, primed all the fluids and performed patient precision.The customer was subsequently able to run calibration and controls 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 (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 service manual, section 6- sampling needle replacement states the following: the 6.4.1 sampling needle replacement.The sampling needle replacement requires access to the inside of the analyzer.Be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during handling.Follow the procedure on page 6-5, "6.3.3 needle cover removal", and remove the needle cover.You will see the sampling needle unit back in the middle.Grasp the upper part of the sampling needle unit by hand and slowly pull the unit forward as much as possible.Since a small volume of reagent will spill during replacement, place a lab wipe under the sampling needle tip.By hand, loosen and remove the joint connected to the 3-way block.Remove the screws on the upper section of the sampling needle.Be careful not to drop the screws or the holding plate inside the machine during this operation.Remove the screws holding the stay, through which the tubing passes.Slowly lift up the sampling needle to remove.Insert the new sampling needle and secure the upper plate with the screws.When you do so, make sure that the needle tip hole is oriented forward.Pass the tubing through the stay, secure with the screw, and securely connect the joint to the 3-way block.Move the sampling needle unit back and forth and confirm that the tubing does not catch anything.If necessary, loosen the screws, turn the sampling needle, and change the stay direction to prevent the tubing from catching anything.Push the sampling needle unit back and attach the needle cover.Keep the following points in mind during replacement: be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during sampling needle replacement.Take care not to touch the end of the sampling needle.If the needle is bent immediately after replacement, check that the primary tubes match the sample rack or sample rack adapter.If the needle placement is clearly off center of the primary tube, it must be adjusted.Change the "y-samp" parameter.Refer to page 4-16, chapter 4.Dispose of the used sampling needle as infectious waste according to the procedures at your facility.Total area: 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.The most probable cause of the reported event was due to fault/ failure of the sampling needle assembly.

Event Description

It was reported that the customer experienced low total area on all samples with their g8 analyzer.The customer verified the waste flow and replaced the sampling needle assembly; but the issue persisted.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.

• 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: 7545221
• MDR Text Key: 109770450
• Report Number: 8031673-2018-00482
• 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: 8 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: 06/01/2009
• 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