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

Model Number G8

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 11/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived onsite to address the reported event.Fse cleaned and lubricated the guide rods for the sampling system.Fse was subsequently able to run quality control (qc), precision, and patient sample (for precision and retention time adjustment only).No further issues were noted.No further action was required by fse.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 18oct2017 through aware date (b)(6) 2018.There were two similar complaints identified during the search period.The g8 variant analysis mode operator's manual under chapter 6- troubleshooting, states the following: 6.3 error messages- when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages- with these errors, the assay stops and the analyzer immediately enters the stand-by state.709 y1-axis error- operation error in y1-axis; unexpected home sensor and limiter sensor signals are monitored during y1-axis operation (refer to error log in "4.10 how to read the log"); a) incorrect y1 mechanism operation: y1 motor fault, drv2 board fault d) cb1 board fault e) asm board fault; inspect the y1 mechanism, inspect the y1 motor, inspect sensors, inspect boards.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 guide rods and sampling system requiring lubrication.

Event Description

The customer reported hearing a loud noise and receiving "709 y1-axis"error with their g8 analyzer.Technical support (ts) instructed the customer to check the samples needle and try to run with the door open to observe operation.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient result for hemoglobin a1c (hba1c).There was no indication of any 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 105-8 623; JA 105-8623
• 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,
• MDR Report Key: 8144831
• MDR Text Key: 131000921
• Report Number: 8031673-2018-05310
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2018
• Distributor Facility Aware Date: 11/18/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/08/2018
• Date Manufacturer Received: 11/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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