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

Model Number G8

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On25apr2018, fse arrived at the site to address the reported event.Fse performed troubleshooting, and then checked the sampling needle assembly.Inspection of the component revealed that the needle was partially clogged.Fse replaced the clogged needle.He was subsequently able to run patient samples with total areas verified to be within range.The replaced part was disposed of by the site.No further issues were noted.No further action was required by field service.A (b)(4) complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were no similar complaints identified during the search period.The g8 service manual - chapter 6- assembly and disassembly (machinery), 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.1) follow the procedure on page 6-5, "6.3.3 needle cover removal", and remove the needle cover.2) 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.3) since a small volume of reagent will spill during replacement, place a lab wipe under the sampling needle tip.4) by hand, loosen and remove the joint connected to the 3-way block.5) 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.6) remove the screws holding the stay, through which the tubing passes.Slowly lift up the sampling needle to remove.7) 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.8) pass the tubing through the stay, secure with the screw, and securely connect the joint to the 3-way block.9) 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.10) push the sampling needle unit back and attach the needle cover.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 most probable cause of the reported event was due to a clogged sampling needle assembly.

Event Description

On (b)(6) 2018, the customer reported high total areas on patient samples with their g8 analyzer.The customer consistently has a high volume; running 200 hemoglobin a1c (hba1c) samples per night.Technical support (ts) instructed the customer to run five samples on both analyzers and compare the total areas.The complaint analyzer received results with total areas 300-500 (*acceptable ranges for whole blood 500-4000) higher than its comparison.Ts also instructed the customer to place "a couple of racks" at a time to prevent the samples from settling out.The customer stated they would try this method over the next few days to see if this helped to resolve the issue.Ts would follow up with the customer at the end of the following week and would email the field service engineer (fse) that performed the periodic maintenance the week prior to acquire information on the service performed.On 19apr2018, ts followed up with the customer via phone.The customer reported that the evening shift did not communicate any issues with high total areas the night prior.The customer further stated that the column was due to be changed that day or the day after.On 24apr2018, ts contacted the customer again for follow up.The customer reported they received at least 20 "area high" flags on samples throughout runs associated with the complaint device.A fse was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4).

• 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: 7489364
• MDR Text Key: 108098722
• Report Number: 8031673-2018-00374
• 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,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2018
• 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: 07/05/2018
• Distributor Facility Aware Date: 06/25/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/05/2018
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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