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

Model Number G8

Device Problems Bent (1059); Device Displays Incorrect Message (2591)

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

Event Date 05/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).While on site, fse replaced the bent sampling needle assembly with a new one.Subsequent recalibration and quality control (qc) results were within range.Additionally, the test count was noted to be 19964 and column count (cc) at 2254 injections.No further issues were noted.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 26apr2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 service manual chapter 4 - assay operations & machinery & the g8 variant analysis mode operator's manual under chapter 6 trouble shooting were reviewed.The g8 variant analysis mode operator's manual under chapter 6, trouble shooting, 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.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 g8 service manual under chapter 6-assay operations & machinery indicates that: if the needle is bent immediately after replacement, check that the primary tubes match the sample rack or sample rack adapter.If the needle placement is clearly off-center of the primary tube, it must be adjusted.Change the "y-smp" parameter.Refer to page 4-16.If the primary tubes are loose on the tosoh rack, adjust the rack's holder to tightly hold the primary tubes.The sampling needle could be bent if the tubes are loose.Insert the primary tubes straight into the racks.If the primary tube is not set straight or its bottom is not fit to the rack, the sampling needle could be bent.The most probable cause of the reported event is due to a bent sampling needle assembly.

Event Description

It was reported that the field service engineer (fse) received "710 z1-axis error" and noted that the sampling needle assembly was bent with the customer's g8 analyzer.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 10586 23; JA 1058623
• 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, CA 94080 ; 6506368123
• MDR Report Key: 7605788
• MDR Text Key: 112153014
• Report Number: 8031673-2018-00545
• 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

• 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: 06/15/2018
• Distributor Facility Aware Date: 05/26/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/15/2018
• Initial Date Manufacturer Received: 05/26/2018
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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