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

Model Number G8

Device Problems Imprecision (1307); Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

The tosoh field service engineer (fse) went to the customer site to perform preventive maintenance (pm) on the g8 analyzer and identified a problem with the inlet and outlet check valves of the pump.The analyzer was repaired by replacing both valves.Following, the fse verified proper precision and operation of the g8 analyzer.The most probable cause of the poor precision is related to failure of the inlet and outlet check valves.The g8 service, operator's and training manuals were reviewed and found to clearly address calibration, quality controls, operation, maintenance, error codes, and troubleshooting pertaining to the g8 system.The g8 training manual informs the user of the following: precision is the reproducibility of an assay and is measured by running a specimen multiple times.Precision can be checked at a single level or across several levels.A tosoh bioscience representative will perform a 20-point within run precision study during instrument installation to validate the performance of the analyzer unless the laboratory provides their own internal protocol.The specimens used to determine assay precision must be similar to routine patient specimens.To verify the manufacturer's claim, specimens should have values that are within the stated linear range on the analyte specification sheet.The g8 operator's manual informs the user of the following: 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.(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).

Event Description

On (b)(6) 2016, the customer called tosoh technical support to report poor precision with use of their g8 analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court, ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7391005
• MDR Text Key: 104277300
• Report Number: 8031673-2018-02248
• 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: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2018
• Distributor Facility Aware Date: 06/21/2016
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/02/2018
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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