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

Model Number G8

Device Problems Decrease in Pressure (1490); Infusion or Flow Problem (2964)

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

Event Date 08/17/2018

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 spoke with the customer over the phone.The fse advised the customer to perform several drain flushes to push the air out of the system after replacing the filter.All errors cleared and the g8 instrument is operational.No further action is required by field service.A 13-month complaint/service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from 17 july 2017 through 17 aug 2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting is as follows: 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 for the reported event was there was air in the instrument's lines.

Event Description

A customer reported error 101 pressure low displayed after the filters were changed on the g8 instrument.The customer tried three different filters on the instrument.There was no leak.Technical support (ts) advised the customer to check the peek tubing tip that enters the filter; there were no issues found with the tubing.Ts also advised the customer to check the buffer volume.Buffer 3 was low.The customer changed and primed the buffer but the pressure was still low.The customer is unable to run patient samples on hba1c diabetes assay.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: 7877417
• MDR Text Key: 123534804
• Report Number: 8031673-2018-00830
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• 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: 09/14/2018
• Distributor Facility Aware Date: 08/17/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/14/2018
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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