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

Model Number G8

Device Problems Low Readings (2460); Device Displays Incorrect Message (2591)

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

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Fse arrived on site to address the reported event.Fse verified the errors, then replaced the clogged sampling needle assembly.Fse was subsequently able to run calibration, precision, and quality control (qc) without errors.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 (b)(6) 2017 through aware date 15jun2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 6- troubleshooting, states the following: the 200 area low error three successive results below the lower limit of the total area (50) occur.If the error message is present when sufficient volume of sample is set in the rack, the problem may be caused by an empty reagent (hemolysis & wash solution).Check the remaining volume of hemolysis & wash solution and start the assay again.The 706 syringe-l error explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.Chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.The most probable cause of the reported event was due to a clogged sampling needle assembly.

Event Description

It was reported that the customer received the "200 area low "error and no peaks with their g8 analyzer.The customer stated that the analyzer had been sitting idle after running samples the day before and when they attempted to run quality control (qc), results returned with low area and no peaks.The customer attempted to troubleshoot by changing the filter; however the issue persisted.The customer stated that they did not have a spare sampling needle assembly on site.Technical support (ts) instructed the customer to remove the sampling needle assembly and flush with diluent water.The customer replaced the part and restarted; however, now they received the "706 syringe-l" error.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.

Manufacturer Narrative

A review of the photographic image provided by the fse confirmed that the sampling needle assembly was clogged.The most probable cause of the reported event was due to a clogged sampling needle assembly.(b)(4), per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• 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
• MDR Report Key: 7653257
• MDR Text Key: 113251902
• Report Number: 8031673-2018-00618
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2018
• Distributor Facility Aware Date: 08/02/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/11/2018
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1