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

Model Number G8

Device Problems Mechanical Problem (1384); Decrease in Pressure (1490)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) contacted the customer over the phone to address the reported event.During troubleshooting, the customer informed fse that they had set the flow factor to 1.57 ml/min, which increased the pump pressure.This is what caused the leak.The customer adjusted the flow factor back to 1.12 ml/min and the pressure went back to normal.The instrument was working as expected.No further action was required by the fse.A 13-month complaint history review and service history review on g8 serial number (b)(4) from 12-nov-2017 through (b)(6) 2018.There were three similar reported issues, including this event, found during the searched period.The g8 operator's manual under chapter 3, assay operations, section 7, states the following: other items to check: check the flow line connections, particularly the filter and the column inlet and outlet for leaks during warming up operations.Tighten the connection if a leak is found.The g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why: on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause of the reported issue was due to incorrect flow factor setting by the customer which lead to increased pump pressure and the reported leak.

Event Description

A customer reported that the prefilter assembly at the peak tubing was leaking on the g8 instrument.The customer stated that the wing nut was broken which resulted in low pressure.The system was down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay of 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 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; 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: 8209426
• MDR Text Key: 132537375
• Report Number: 8031673-2018-05382
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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: 01/02/2019
• Distributor Facility Aware Date: 12/12/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/02/2019
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2012
• 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