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

Model Number G8

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineer (fse) found the filter was possibly clogged and the filter housing was very tight on the filter, restricting flow.The fse checked the fluidic lines and column, installed a new filter, and g8 analyzer operated without any error messages.The fse then proceeded to run quality controls and patient samples, which passed.The g8 analyzer was working in accordance to the manufacturer's expectations; no further action was required.A 13-month complaint and service history review was performed on serial number (b)(4) for similar complaints from 25-aug-2016 through aware date (b)(4) 2017.No other similar complaints were identified during the searched period.G8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 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 a clogged filter.This report is being submitted due to an internal nonconformance identified.(b)(4).

Event Description

A customer reported receiving error message "100 pressure high" with their g8 analyzer.The customer reported that pressure was over 21 megapascal (mpa).The technical support specialist (tss) had the customer disconnect the peek tubing on the output side of the pre-filter housing and pressure was 0.1 mpa.The tss then instructed the customer to disconnect the peek tubing on the input side of the column and the pressure was 21 mpa (upper limit is 15 mpa).The customer required service in order to investigate the issue.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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 105-8 623; JA 105-8623
• 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: 8162915
• MDR Text Key: 131341220
• Report Number: 8031673-2018-05321
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2018
• Distributor Facility Aware Date: 09/25/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2018
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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