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 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer (fse) followed up with customer over the phone.Fse instructed customer to turn on the pump manually while buffer #1 valve is open, and open buffer#2 valve every 5 seconds intervals for several minutes.Customer confirmed that fixed the instrument and the pressure is back to acceptable range.On (b)(6) 2018, fse followed up with customer to schedule a visit to replace the buffer#2 valve and customer declined service, stating that instrument has been running within specification without any errors.Customer confirmed he ran controls successfully and results were within acceptable range and pressure is steady.The g8 was performing within manufacturer's specifications; no further action was required by the fse.A 13-month complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.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: 101 pressure low the pressure will not rise because the pump is unable to run due to air bubbles in the pump check valve.If the elution buffer is empty, place a new elution buffer and execute reagent change.Next, execute drain flush.See "chapter 5 section 5.5: pump air removal".Execute manual pumping using the pump key in the main screen (second screen), and open and close the drain valve 2 or 3 times.If the pressure rises when the drain valve is closed, the operation is complete.If the pressure still does not rise or stabilize, execute drain flush again.In addition, confirm that the drain valve is securely closed.The most probable cause of the reported event was due to operator error; air bubble in the system due to running 60 samples while the buffer 2 was empty.

Event Description

On (b)(6) 2018, a customer reported getting 101 pressure low error message on the g8 instrument.Customer stated that buffer #2 has been out for some time before it was realized.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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7430954
• MDR Text Key: 105763612
• Report Number: 8031673-2018-00305
• 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: 04/13/2018

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: 04/13/2018
• Distributor Facility Aware Date: 03/15/2018
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2010
• 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