MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Fse followed up with the customer over the phone to address the reported event.Fse informed the customer that he would be sending her tri-flo lubrication.Next, fse instructed the customer on how to lubricate the z1-axis shaft, screw drive, and the y-axis rails.Fse also advised the customer to call back with any questions.Fse followed up with the customer and they stated that they no longer had any issues after lubricating the parts.Fse advised the customer to contact technical support (ts) if they have any more issues.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 24apr2017 through aware date 24may2018.There were no 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.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 z-axis lacking lubrication.

Event Description

It was reported that the customer received "710 z1-axis"errors while running controls with their g8 analyzer.Technical support (ts) instructed the customer to turn the analyzer off and clean the sample needle assembly guide rod.While cleaning and moving the sample needle from front to back, the customer noticed that it was not moving back and forth smoothly.The sample needle assembly was also making a grinding noise.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.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gatz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, IC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7605793
• MDR Text Key: 112152541
• Report Number: 3005529799-2018-00540
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2015
• 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