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

Model Number G8

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse found the hemolysis & wash (h/w) tubing sinker was not submerged in the h/w and dilution well.The fse also found a lack of wash entering the system.The fse cleaned the dilution well and ran samples to test operation.The fse ran 20 samples without error; calibrated the analyzer, then ran quality controls and precision.All results were within acceptable range.All errors cleared and the g8 instrument was operational.No further actions were required by field service.A 13-month complaint / service history review for similar complaints was performed for the serial (b)(4) from aware date of (b)(6) 2018, which included data from 4/21/2017 through (b)(6) 2018.There were two similar complaints identified during the searched period for low total areas and there were two similar complaints identified during the searched period for missing peaks, which includes this event.The g8 operator's manual under chapter 1 and chapter 6 troubleshooting are as follows: 1.4 storage and stability columns are warranted for 2500 injections.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.The 200 area low error 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 and wash solution).Check the remaining volume of hemolysis and wash solution and start the assay again.Error message: 200 area low error explanation: the peak area which does not reach the minimum required area (50) occurred three times in series.Countermeasure: check the samples, buffers, and hemolysis and wash solution.The 220 no peak detect no peaks could be detected.This problem could be caused by different scenarios.Insufficient sample uptake due to a coagulated sample may have been processed or a short sample was processed.The most probable cause for the reported event was the column count (cc) was greater than 2500.The cc was 2840.The h/w tubing was not submerged in the wash.

Event Description

A customer reported low total areas were generated on patient samples on the g8 instrument.The customer stated that the peaks were abnormal.The technical support specialist (tss) advised the customer to change the column because it was over 2500 injection counts and to change the sample needle assembly.The customer requested assistance with changing the sample needle assembly and did not have a replacement onsite available to change the one in use.The customer also found that the waste was backing up.The customer attempted to clear the liquid and to run a sample but the system still generated low total areas and missing peaks.Tss sent the customer a sample needle assembly.The customer was unable to run patient samples on hba1c.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: TOSOH HLC-723GA 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; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; ste. 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7590796
• MDR Text Key: 110725951
• Report Number: 8031673-2018-00518
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• 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: 06/12/2018
• Distributor Facility Aware Date: 05/21/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/12/2018
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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