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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse confirmed the reported error thru the error log.Fse replaced the sample needle due to it being slightly bent.Patient sample were run multiple times with no errors reported.Fse reviewed the data and it was noticed that the total areas were on the lower end of the range, therefore, the small syringe was replaced to resolve that issue.The instrument is functioning as intended and was released.No further actions are required by the fse.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the 30th of april 2017 through awareness date on the (b)(6) 2018.There was one (1) similar complaint identified during the searched period.The g8 variant analysis mode operator's manual under chapter 5, maintenance procedures states the following: error message: 710 z1-axis error, explanation: operation error in z1-axis, countermeasures: inspect z1-axis.Execute smp.Reset.Replace the sampling needle if it is bent or broken.Use the following procedure to replace the sampling needle.Access to the inside of the analyzer is needed to replace the sampling needle.Be sure that only personnel who have been trained by tosoh or its representatives perform these operations.Be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during handling.Take care not to touch the end of the sampling needle during handling.Turn the power key and main power switch off to stop the analyzer operations during needle replacement.The sampling needle unit cannot be drawn unless the power key is off.Open the left-side door and loosen two needle cover screws indicated in fig.5-11.You do not need to remove the screws.Open the door below the display and loosen one needle screw indicated in fig.5-11.Grasp the needle cover, push it inward while taking care not to break it, and remove it from the needle screw indicated in 3) above.Once you verify that the cover has been removed from the screws shown in fig.5-11, remove the cover by pulling it straightforward.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 of the sampling needle flow line.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.See fig.5-12.Remove the tube from the black clip.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.Fix the flow line by the black clip so that it doesn't twist, and then securely connect the joint to the 3-way block.Move the sampling needle unit back and forth and confirm that the flow line does not catch on anything.If necessary, loosen the screws, turn the sampling needle, and change the stay direction to prevent the flow line from catching on anything.Push the sampling needle unit back, close the sampling unit cover by following the procedure in reverse, and secure the screws.Turn on the main power and return the analyzer to stand-by state.Assay a dummy sample or control to confirm that the sample aspiration is processed correctly (see the total area in the result should be about the same as before the sampling needle replacement).If the needle becomes bent immediately after replacement, check that the primary tubes match the sample rack or sample rack adapter.If you are using 100 mm tubes, the finger guard must be removed.If the needle placement is clearly off center of the primary tube, it must be adjusted.Cancel the assay and contact technical support.Dispose of the used sampling needle as infectious waste according to the procedures at your facility.(b)(4).

Event Description

The customer reported receiving 710 z1 axis errors on their g8 instrument.The customer indicated that sample needle tip was bent, the sample needle was replaced and it did not resolve the reported error.Also, customer reported that they utilize hemogard tubes and appears the puncture point is off center.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Device evaluation by manufacturer: the small syringe was returned for investigation.Functional testing was peformed on the small syringe and it did not confirm the failure and error could not be duplicated.The most probable cause of the reported issue was unknown.(b)(4) per exemption number e2017013.

• Brand Name: TOSOH HLC-723G8 ANALYZER
• 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: 7653475
• MDR Text Key: 113180793
• Report Number: 8031673-2018-00564
• 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: 07/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 06/22/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2018
• Distributor Facility Aware Date: 06/22/2018
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/22/2018
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1