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

Model Number G8

Device Problems Occlusion Within Device (1423); Increase in Pressure (1491); Device Issue (2379); Device Operates Differently Than Expected (2913)

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

Event Date 05/19/2018

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 verified the reported event and completed a preventive maintenance.The issue was resolved.The fse found a clog in the injection valve area.The fse verified precision, ran calibration, and ran quality control.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 (b)(4) review for similar complaints was performed for the serial number (b)(4) from aware date of 5/19/2018, which included data from 4/19/2017 through 5/19/2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual codes under chapter 6 troubleshooting are as follows: 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; 102 pres limit over - the pump pressure has risen abnormally and has caused the shutdown circuit to be activated.Turn the main power switch off and remove the cause of the pressure increase.Refer to 100 pressure high.The most probable cause for the reported event was a clog in the injection valve.

Event Description

A customer reported error 102 pres limit over due to a high pressure displaying on the g8 instrument.The g8 was alarming and customer had to power off the breaker switch to stop the alarm.The technical support specialist (tss) advised the customer to repower the analyzer several times.The customer later stated that the error 102 changed to error 100 pressure high.The customer then installed the filter and the pressure was now in range.The customer ran quality control (qc) and a few patient samples which he reported the sa1c rt (retention time) was high and the la1c was not detected.Tss advised the customer to adjust the flow factor but the sa1crt was still not in range and the la1c was not reporting a peak.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: 7590801
• MDR Text Key: 111171679
• Report Number: 8031673-2018-00516
• 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: 05/19/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/12/2018
• Date Manufacturer Received: 05/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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