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

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.During troubleshooting, fse could not duplicate the problem while on site.The error was intermittent.Fse was able to verify the issue with the error logs and patient results.Fse continued visual inspection of the instrument and found the dilution well was scuffed.Fse replaced the dilution block and aligned the sample needle on the dilution block and sample aspirating (loader) positions.Fse found that the small syringe was worn and producing bubbles, which is the cause of inconsistent total areas.Fse replaced the small syringe.Fse continued to evaluate and suspected the injector valve was causing the intermittent high area.Fse also replaced the injector valve.Fse then found that the tube for the line filter was the incorrect tube and replaced it with the correct tube.Fse replaced the large syringe as a precaution.Fse then ran a calibration and quality controls (qc) with acceptable results.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There was one similar complaint identified during the searched period.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 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 intermittent high total areas has not yet been determined.The investigation is in progress.

Event Description

A customer reported that they have continued to get high total areas on a large number of patient samples on the g8 instrument.The customer tried remixing the samples but they continue to get high total areas.The customer reported that one patient's sample had a total area of 4535 on this instrument but when the same sample was run on a different g8 instrument, the total area was 905.Field service was onsite two days later to address the issue but the customer later reported that half of a 20 sample run without caps still had a total area between 2000 and 2500.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 is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: the large syringe, small syringe, sample dilution block, the rheodyne valve with plate, and the column line to pre-heater exit were returned for evaluation.The large syringe was inspected visually and when manually moving it in the testing instrument, the syringe was sticking.The error was duplicated.The part failed testing.The small syringe was visually inspected and was found to have a crack in the glass.The part failed testing.The dilution port block was visually inspected and found to have a physical blockage on one of the port holes.The error was duplicated.The part failed testing.The rheodyne valve with plate was disassembled and visually inspected.The alignment of the packing nut had moved from specifications, which renders the valve useless.The valve could not perform correctly.The error was duplicated.The part failed testing.The column to the preheater was functionally evaluated.The part functioned correctly.The error could not be duplicated.The part passed testing.Small syringe, large syringe, rheodyne valve, sample dilution block evaluation codes: evaluation codes: method: 4109 historical data analysis; 10 testing of actual/suspected device; results: 180 mechanical problem identified; conclusion code: 4307 cause traced to component failure.Column to pre-heater exit evaluation codes: results: 213-no device problem found; conclusion: 67- no problem detected.The most probable cause of the reported event was due to failure of the small syringe, large syringe, rheodyne valve, and the sample dilution block.

• 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
• MDR Report Key: 7943381
• MDR Text Key: 125129562
• Report Number: 8031673-2018-00912
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2019
• Distributor Facility Aware Date: 12/28/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/19/2019
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 01/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1