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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: on (b)(6) 2018, fse was at customer's site and confirmed reported issue from instrument error log.Fse replaced the sample needle and realigned the sample needle to the correct position above the sample rack.Fse completed sample precision test and quality control runs successfully.The g8 instrument is performing within specifications.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 two (2) similar complaints identified during the searched period, which includes this event.Sample needle the g8 service manual under chapter 5 - maintenance procedure, section 5.10 - sampling needle replacement, provides detailed information on how to replace the sample needle.The g8 operator's manual under chapter 6 - troubleshooting, section 6.2 - general system failures states 710 z1-axis error occurs when 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 incorrect alignment of the sample needle above the sample rack.

Event Description

On (b)(6) 2018, customer reported getting 710 z1-axis error message on the g8 instrument.Customer stated they cleaned and lubricated the z axis guide rod and lead screw.Customer also replaced sample needle, but intermittent z1 axis errors still occurred.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 CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 7380222
• MDR Text Key: 103800952
• Report Number: 8031673-2018-00241
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: 03/28/2018
• Distributor Facility Aware Date: 03/01/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/28/2018
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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