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

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900)

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

Event Date 05/19/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, a field service engineer (fse) was dispatched.During the inspection of the instrument, the fse found that the tubing on the drain waste valve was loose.He connected the drain waste tubing, replaced 4 bf wash probe assemblies, and made adjustments.The customer ran calibrations and qc with no issues.A 13-month complaint history and service review for serial number (b)(4) was conducted for similar complaints.There was one (1) similar event reported prior to the reported event.No consequent failures related to the reported event were found in the complaint and service history.The aia-2000 service and operator's manuals were reviewed and found to clearly address calibration, operation, maintenance, and troubleshooting of the aia-2000 system.Further, per the service manual it advises the user to perform the priming operation to ensure that there are no problems related to liquid suction and dispensing.The probable cause of the event was related to the wash probe assembly.(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review under capa(b)(4).

Event Description

On (b)(6) 2015, the customer reported assay issues with their aia-2000 analyzer.No further information was provided.This event is being reported as the customer was unable to run samples which caused a delay in reporting patient samples for fsh, lhii and pth assays.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting results.

Manufacturer Narrative

Additional manufacturer narrative: tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number: e2017013.This report is being submitted due to a retrospective review conducted under capa: 2017-0007.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Device by manufacturer: on (b)(6) 2015, the same day as of the reported event, a field service engineer (fse) called the customer and advised the customer to check for leaks and to ensure the filter cap was properly tightened.The customer confirmed there were no leaks and the cap was tightened.The customer was also advised to adjust the flow rate of the instrument and rerun sample.The customer responded back informing of acceptable chromatogram results and within specifications with regards to the assay.No further action was required by the fse.The g8 instrument was found to perform according to specifications.A 13-month complaint history and service review for serial number: (b)(4) was conducted and no similar events were found.No consequent failures related to the reported event were found in the complaint and service history.Per the g8 operator, service and training manual it is stated the column is warranted for 2500 injections.Further, the training manual provides guidance on how to interpret unusual chromatogram results and advises the users the column may be one of the reasons for the unusual results.In addition the g8 instrument can be programmed where the instrument would alert (flag) the user when the unit has reached 2500 injections and it is time to replace the column.Further, the g8 operator's manual advises on chromatograms from patients with hemoglobin variants or unknown peaks not recognized by the analyzer are occasionally seen during routine testing and are depending on the hemoglobinopathy present, the flow rate, and the condition of the column and reagent system.The most likely cause, based on the information provided by the customer/physician is attributed to the overuse of the column.Corrected data: original mdr#: 3005529799-2018-01003 (supplemental to 3005529799-2018-01003).This mdr contains the correct information as reflected in this submission; however, by mistake an mdr was submitted for a separate event with the same number 3005529799-2018-01003.New mdr number 3005529799-2018-04171 was filed for that separate event.

Event Description

On (b)(6) 2015, the customer called tosoh technical support after receiving discrepant results (i.E.Abnormal chromatograms) on one of their g8 instruments.At the time of the call, the customer informed the technical support specialist (tss) they may have exceeded the column count limit and was advised by the tss to replace the column.The customer called back and reported they were still receiving discrepant results despite replacing the column.A follow up was requested by the customer.There was no indication of any patient intervention or adverse health consequences due to the discrepant 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
• MDR Report Key: 7274669
• MDR Text Key: 100470011
• Report Number: 8031673-2018-01003
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• 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: G8: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2018
• Distributor Facility Aware Date: 05/19/2015
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/16/2018
• Date Manufacturer Received: 05/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1