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

Model Number G8

Device Problem Imprecision (1307)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018, fse contacted the customer via phone to address the reported event.Inspection of the device revealed that the sample needle assembly was slightly bent and that one of the adapters over the trays was missing; resulting in the sample needle assembly being bent.The customer replaced the probe with another one he had on site.No further qc issues were noted.No further action was required by field service.A (b)(4) 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 no similar complaints identified during the search period.The g8 service manual chapter 6 - assembly and disassembly (machinery) was reviewed.The 6.4.1 sampling needle replacement.The sampling needle replacement requires access to the inside of the analyzer.Be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during handling.Follow the procedure on page 6-5, "6.3.3 needle cover removal", and remove the needle cover.You will see the sampling needle unit back in the middle.Grasp the upper part of the sampling needle unit by hand and slowly pull the unit forward as much as possible.Since a small volume of reagent will spill during replacement, place a lab wipe under the sampling needle tip.By hand, loosen and remove the joint connected to the 3-way block.Remove the screws on the upper section of the sampling needle.Be careful not to drop the screws or the holding plate inside the machine during this operation.Remove the screws holding the stay, through which the tubing passes.Slowly lift up the sampling needle to remove.Insert the new sampling needle and secure the upper plate with the screws.When you do so, make sure that the needle tip hole is oriented forward.Pass the tubing through the stay, secure with the screw, and securely connect the joint to the 3-way block.Move the sampling needle unit back and forth and confirm that the tubing does not catch anything.If necessary, loosen the screws, turn the sampling needle, and change the stay direction to prevent the tubing from catching anything.Push the sampling needle unit back and attach the needle cover.Keep the following points in mind during replacement: be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during sampling needle replacement.Take care not to touch the end of the sampling needle.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-samp" parameter.Refer to page 4-16, chapter 4.Dispose of the used sampling needle as infectious waste according to the procedures at your facility.The most probable cause of the reported event was due to a bent sampling needle assembly.

Event Description

On (b)(6) 2018, the customer reported that the g8 analyzer was not providing quality control (qc) results.The customer reported that qc had erratic peaks and no total area.Fresh qc was made the week prior and the day of the reported event at 1:110 dilution.The analyzer did provide results for patient samples.Technical support (ts) instructed the customer to make a dilution of the sample he ran that was normal; however, the issue did not resolve.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for 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: 7478570
• MDR Text Key: 107569235
• Report Number: 8031673-2018-00396
• 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: 05/01/2018

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: 05/01/2018
• Distributor Facility Aware Date: 04/11/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/01/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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