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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

The tosoh field service engineer (fse) went to the customer site to evaluate the g8 analyzer and perform preventive maintenance (pm) on the instrument.The fse found that no cycle count was entered and the instrument had reached over 23,000 cycles.Following pm, operation of the g8 analyzer was verified.Calibration, quality controls and precision testing were performed and all were within acceptable range.In addition, the fse set the flag for 20,000 cycles to alert the customer to schedule the next pm.The most potential causes of the high pressure may be related to malfunction of the grad sensor and/or a clogged filter or column.Review of the g8 variant analysis mode operator's manual provides the following information: 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.Yearly maintenance is due at 20,000 cycles.Columns are warranted for 2500 injections.Change filter after 400 injections.(b)(4).This report is being submitted due to a retrospective review conducted under (b)(4).

Event Description

On (b)(6) 2016 the customer called tosoh technical support to report getting an error code (150 grad sensor error) and high pressure reading during use of the g8 analyzer.The customer reported replacing the filter twice and the column to correct the pressure.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of patient results for hba1c.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court, ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7347903
• MDR Text Key: 103009092
• Report Number: 8031673-2018-02227
• 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: 03/18/2018

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2018
• Distributor Facility Aware Date: 06/09/2016
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/18/2018
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 03/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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