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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: on 13-mar-2018, a field service engineer spoke with technical support and suggested to advise the customer to replace the column.The customer replaced the column and pressure was 8.6 mpa.The tss advised the customer to run five (5) patient samples to prime the new column and then calibrate the g8 instrument and run quality controls (qc).The customer reported that qc was within acceptable range the g8 instrument was functioning as designed.No further action was required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 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.The 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: greater than the pressure on the column inspection report + 4 mpa, then replace the filter.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 faulty column.(b)(4).

Event Description

On (b)(6) 2018, a customer reported getting 100 pressure high error message on the g8 instrument.The customer had called technical support earlier during the day to request assistance on how to tight the wing nut on the filter.The customer reported that the nut was tight and the pressure was 12.5 mpa; however, when the nut was loosened the pressure would go down.The customer reported that the filter had been replaced three (3), which eliminated the possibility of this being the cause of the high pressure issue.The customer reported that the column was new with only 489 injection counts (2500 injection counts maximum recommended).The customer reported that the issue began happening before the column was replaced.The customer refused to perform any further troubleshooting and requested service in order to address the reported issue.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 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 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: 7405579
• MDR Text Key: 105275418
• Report Number: 8031673-2018-00274
• 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: 04/07/2018

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: 04/07/2018
• Distributor Facility Aware Date: 03/09/2018
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/07/2018
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2008
• 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