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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer's site to address the reported event.Fse was able to reproduce error when the instrument was powered up.Fse replaced the faulty sample needle, cleaned and lubricated sampling mechanism.Fse successfully completed quality control without any errors.No further action required by field service.The g8 instrument is functioning as expected.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) through aware date.There were no similar complaints identified during the search period.The g8 variant analysis mode operator's manual under chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.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 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 the faulty sample needle.

Event Description

A customer reported getting frequent 710 z1-axis error messages during sample run on the g8 instrument.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 is 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: 8280119
• MDR Text Key: 136147974
• Report Number: 8031673-2018-05443
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/25/2019
• Distributor Facility Aware Date: 12/31/2018
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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