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

Model Number G8

Device Problem Noise, Audible (3273)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On19apr2018, fse arrived at the site to address the reported event.Investigation of the device revealed that the large & small syringe rods and screws were dry and dirty.Fse cleaned and lubricated the large and small syringes and the sampling needle assembly rod and screw.He was subsequently able to run precision, controls, and verify instrument operation.No further issues were noted.No further action was required by field service.A (b)(4) complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the search period.On19apr2018, fse arrived at the site to address the reported event.Investigation of the device revealed that the large & small syringe rods and screws were dry and dirty.Fse cleaned and lubricated the large and small syringes and the sampling needle assembly rod and screw.He was subsequently able to run precision, controls, and verify instrument operation.No further issues were noted.No further action was required by field service.A (b)(64 complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the search period.The g8 variant analysis mode operator's manual under preface safety precautions, states the following: contact technical support: blood to be tested might have been infected by (a) pathogen(s).Misconduct on repair or disposal may bring infection to you or others working together.In the case of repairing and disposing, please contact technical support.The most probable cause of the reported event was due to dirty large syringe rods & screw.

Event Description

On (b)(6) 2018, the customer reported a loud, high-pitched, squealing noise during washing with their g8 analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delay in reporting of patient results for hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Corrected data: device evaluation was inadvertently duplicated on the initial report.On 19apr2018, fse arrived at the site to address the reported event.Investigation of the device revealed that the large & small syringe rods and screws were dry and dirty.Fse cleaned and lubricated the large and small syringes and the sampling needle assembly rod and screw.He was subsequently able to run precision, controls, and verify instrument operation.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the search period.Updated most probable cause: the most probable cause of the reported event was due to dirty large and small syringe rods & screws.(b)(4).

• 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: 7491674
• MDR Text Key: 108097145
• Report Number: 8031673-2018-00414
• 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,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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: 07/05/2018
• Distributor Facility Aware Date: 06/25/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/05/2018
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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