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

Model Number G8

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived on site to address the reported event.Inspection of the device revealed that the sample needle assembly tubing was too tight.Fse rerouted the tubing, then cleaned and lubricated the lead screw and rod.Fse was subsequently able to run quality control (qc) and calibration without issue.No further action was required by field service.A 3 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4).There were no similar complaints identified during the search period.The instrument was installed at the account on (b)(6) 2018.The g8 operator's manual under chapter 6- troubleshooting, states the following: the 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 stand-by state.The 710 z1-axis error: an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The most probable cause of the reported event was due to the sample needle assembly tubing being too tight.

Event Description

It was reported that the customer received intermittent "710 z1-axis" error with their g8 analyzer.The customer stated that the error occurred at the end of a full rack and said that "the rack seemed to lift up, give the error, then shut off".The customer successfully performed a rack rotate and smp reset without errors; but afterwards stated that the specimen tube caps seemed to be punctured slightly off center.Next, the customer attempted to run with the caps off and did not place any tubes at the end of the rack; however, the error persisted.A 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.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number 2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• 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
• MDR Report Key: 7707674
• MDR Text Key: 114940011
• Report Number: 8031673-2018-00621
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• 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: 12/10/2018
• Distributor Facility Aware Date: 11/15/2018
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/10/2018
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1