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

Model Number G8

Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)

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

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

(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).A field service engineer was dispatched on (b)(6) 2017.The fse conducted a service call over the phone to address the reported event.During the call, fse assisted the customer with re-priming all fluidics and helped them to establish normal pressure levels on all buffers.The customer was then instructed to prime the hydrolysis wash and drain flush.The customer verified that the pressure was steady and back to normal without any leaks.Customer ran controls and achieved normal recoveries.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was failure of the high pressure pump system.

Event Description

On (b)(6) 2017 a customer reported high pressure and y axis errors with their g8 analyzer.The customer reported that they changed the column and filter but the pressure remained high.A field service engineer (fse) spoke to the customer to troubleshoot the event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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: 7372063
• MDR Text Key: 103919296
• Report Number: 8031673-2018-04414
• 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: 03/26/2018

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: 03/26/2018
• Distributor Facility Aware Date: 02/17/2017
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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
• Patient Outcome(s): Congenital Anomaly; Death