MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8; G8, PRODUCT CODE: LCP

Model Number G8

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Operates Differently Than Expected (2913)

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

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted due to a retrospective review conducted under capa(b)(4).(b)(4).The field service engineer (fse) was dispatched on 13 january 2017.During the investigation the fse made a new line for the instrument from the 6-way valve port #4 to the pressure pump lower back port for the diaphram wash.The fse also replaced the pump, verfied all connections were secure, primed the system, and adjusted the pump flow rate from 1.10 to 1.01.The fse ran precision , quality control and patient samples and the results were within specification.The g8 was working as intended.No further action required by fse.The probable cause of the event was due to a malfunctioning pump.

Event Description

On (b)(6) 2017 a customer reported receiving intermittent low total area with their g8 analyzer.The diluted total area was 1787 and 1374.Capped samples total areas were 672, 689 and 668.The uncapped samples total area were 589, 795, and 1016.The customer was unable to run samples and requested service to address the reported event.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay reporting hba1c patient results.There was no indication of any patient intervention or adverse event consequence due to the delay of reporting patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8, PRODUCT CODE: LCP
• 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; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7322993
• MDR Text Key: 102078480
• Report Number: 8031673-2018-01465
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• 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: 03/08/2018
• Distributor Facility Aware Date: 01/13/2017
• Device Age: 11 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/08/2018
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2005
• 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