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

Model Number G8

Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer (fse) visited the customer to address the reported event.During the initial evaluation, the instrument was operational with a pressure of 9.15mpa.Further evaluation found the peek tubing from the prefilter to the preheater kinked.The fse replaced the peek tubing.Fse requested to review chromatograms for the high pressure issues but the customer was only able to produce one for an sa1c with a retention time of 0.65 or higher due to a leak in the prefilter.After further investigation, the customer stated that the high pressures were as a result of an operator running samples with clots in them.No calibration or precision was needed for the instrument.The customer ran quality controls, which were within range.The g8 instrument was working as designed.No further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 13-mar-2017 through aware date 13-apr-2018.There were no similar complaints found.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 6.3 error messages when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages with these errors, the assay stops and the analyzer immediately enters stand-by state.100 pressure high the pump pressure exceeded the upper limit (15 mpa) set in the pres high parameters.When the filter or column replacement period has been exceeded, first replace the filter or column.If the pressure is still high, remove the inlet and outlet flow line around the column and filter, and determine which part is the cause of the high pressure.Then, contact a technical support representative.If the pressure displayed on the screen is: (a) greater than the pressure on the column inspection report + 4 mpa, then replace the filter.(b) less than the pressure on the column inspection report, then proceed with priming the column.The most probable cause of the reported event was due to kinked peek tubing from the prefilter to the preheater.

Event Description

On (b)(6) 2018, a customer reported getting intermittent 100 pressure high error messages with the g8 instrument.The customer reported that they had been replacing the filter twice weekly due to the high pressure errors.They stated that the instrument will run within pressure specifications then suddenly jump to a high pressure.A discrepant result of sa1c <4% is flagged and abnormal chromatographs would occur with pressures at 12 or higher.They tried replacing the prefilter and rebooting the instrument, but the intermittent high pressures persisted.The customer stated that the results were not reported out and there were no diagnostic decisions made on the results.The discrepant samples were repeated after the prefilter replacement with any delay.The customer also reported that the total area and the sa1c retention time (rt) were within specifications.The customer could not do pressure tests at the time of the incident.A field service engineer (fse) was dispatched to address the reported event.The event was likely to cause discrepant 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.

• 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: 7486278
• MDR Text Key: 107995737
• Report Number: 8031673-2018-00403
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 05/04/2018
• Distributor Facility Aware Date: 04/13/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/04/2018
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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