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

Model Number G8

Device Problems Mechanical Problem (1384); Failure to Align (2522); Mechanical Jam (2983)

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

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.Fse conducted follow-up with the customer over-the-phone to address the reported event.The fse advised the customer to check x1 axis and rack advancement to the sampling position.Customer reported back that the sampling position is aligned and centered on the x1 axis.Fse verbally provided instructions to align y1 axis to sample loader to sample primary tube.The fse instructed the customer to change the y1 axis steps from 3290 to 3225 steps on the y1 axis.Then the fse had the customer check the alignment through verbal instructions and y1 axis is aligned the center of a 75 mm primary tube.Fse instructed the customer to reinstall covers, save parameters, and power off instrument.Then the fse had the customer power up instrument, prime instrument fluidics , run quality controls (qc) and a precision run with a known whole blood sample sa1c value of 6.0% n=10 times.All the results were within specification and without any errors.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 22nd of may 2017 through awareness date on the 22nd of june 2018.There were two (2) similar complaints including this one identified during the searched period.The g8 variant analysis mode operator's manual chapter 5 maintenance procedures states the following: sampling needle replacement.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.You do not need to remove the screws.Open the door below the display and loosen one needle screw.Grasp the needle cover, push it inward while taking care not to break it, and remove it from the needle screw.Once you verify that the cover has been removed from the screws, 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.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.The most probable cause of the reported issue was due to y1 axis on sampling unit out of alignment.(b)(4).

Event Description

The customer reported a bent sample needle assembly for their g8 instrument.Customer replaced the sample needle and observed that sample needle y-axis was out of alignment.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.

• 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
• 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: 7705368
• MDR Text Key: 114937626
• Report Number: 8031673-2018-00643
• 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: Other
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2018
• Distributor Facility Aware Date: 06/22/2018
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/19/2018
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2009
• 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