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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse confirmed the high pressure errors on the g8 instrument.Fse performed troubleshooting and found tube i-6 from the injection valve to the filter housing to be clogged.Fse flushed out the tubing with a syringe and cleared the clog.Upon initialization the pressure stabilized at 8.45 mpa, and observed that the parameters had been dumped as analyzer was turned off at main power for over 24 hours.Fse restored the parameters utilizing printout from valve door and verified the reporting software was transmitting data correctly.Fse then ran quality controls (qc); all results passed within acceptable range and the pressure within specification range.The g8 instrument was performing as intended and the errors cleared.No further action was required from field service.A 13-month complaint history review and service history review for serial number (b)(4) from 04-mar-2017 through aware date 04-apr-2018 for similar complaints was performed.There were no similar complaints identified during the searched period.The g8 operator's manual under chapter 6 - troubleshooting, provides guidance on error 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.A 150 grad sensor error is generated when the grad sensor on the pump malfunctioned.The customer is to check the sensor for proper operation.The most probable cause of the reported event was due to a clog in line i-6 from injection valve to the filter housing.

Event Description

A customer reported getting error 100 pressure high and error 150 grad sensor error on the g8 instrument.Customer reported the pressure went up to > 24 mpa (<15 mpa is max transport pressure).Technical support specialist (tss) had the customer remove the filter assembly and run the pump without the filter or filter cap in place, but the pressure was still > 15 mpa.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 was 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
• 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; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7482049
• MDR Text Key: 107858842
• Report Number: 8031673-2018-00377
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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: 05/02/2018
• Distributor Facility Aware Date: 04/04/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/02/2018
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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