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

Model Number G8

Device Problem Device Operational Issue (2914)

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

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse confirmed the reported issue with the error printout from the g8 instrument.Fse found the large syringe guide rods dry and binding.Fse lubricated the guide rods, lead screw, small syringe, and the sampling unit.Fse then ran quality controls (qc) samples; all results were with acceptable range.The error cleared and no grinding noise is heard.The g8 instrument is performing as intended.No further action was required from field service.A 13-month complaint history review and service history review for serial (b)(4) from 09-mar-2017 through the awareness date (b)(6) 2018 for similar complaints was performed.There were two (2x) other similar complaints identified during the searched period.The g8 operator's manual under chapter 6 - troubleshooting, states message 706 is syringe-l error and is generated due to operation error in syringe-l.The countermeasure is for the user to inspect the syringe-l and execute smp.Reset.Also under chapter 5: maintenance procedures outlines and provides guidance for instrument care and maintenance.The customer is to call tosoh support should questions arise.The most probable cause of the reported event was due to the large syringe needed to be lubricated.

Event Description

A customer reported getting message 706 syringe-l error and grinding noise while running patient samples on the g8 instrument.Field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was 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
• 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; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7481896
• MDR Text Key: 107828189
• Report Number: 8031673-2018-00389
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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: 05/02/2018
• Distributor Facility Aware Date: 04/09/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/02/2018
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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