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

Model Number G8

Device Problems Use of Device Problem (1670); Filtration Problem (2941)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This report is being refiled per fda request to indicate initial report type.This report is an "initial" to uf/importer report #: 3005529799-2015-00009.Contact office: (b)(4).Manufacturer name/address: (b)(4).Date received by manufacturer: 20-jul-2015.510k: k071132.Adverse event: follow-up # 1.Type of event: malfunction follow up: correction, additional information.Adverse event codes: (b)(4).Device usage: reuse.Additional information: the most probable cause of the abnormal peaks is related to the extended column life beyond 2500 injections.Review of the g8 variant analysis mode training manual informs the user of the following: columns are warranted for 2500 injections.After column replacement, use the column reset key to reset the column count.Flag 06 may be programmed to alert the operator after 2500 injections are performed with a specific column.When the flag for number of injections is programmed, every specimen that exceeds the limit will be printed with the flag.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(b)(4).

Event Description

On 20jul-2015, tosoh bioscience, inc.Was notified of erroneous patient hba1c results that were reported on 25-jun-2015.The testing was done on a tosoh hplc g8 analyzer, and all quality controls were within acceptable target ranges.Chromatograms were reviewed after the results were reported and it was discovered that the chromatogram peaks looked abnormal and test results should not have been reported.The column count at the time of this event was 3800, and required replacement.Following replacement of the column, calibration was performed and quality controls run.Quality controls were within acceptable range (level 1 result: 6.3, acceptable range: 5.66 - 6.86; level 2 result: 9.4, acceptable range: 8.37 - 9.94), and the chromatogram peaks looked normal.Of the 200 patient results reviewed with abnormal looking chromatograms, approximately 43 specimens in the range of 7.0- to 7.9 were repeated following installation of the new column.The repeated specimen results were lower, and corrected patient results were reported to the ordering physicians.

• 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
• MDR Report Key: 7435119
• MDR Text Key: 261265310
• Report Number: 3005529799-2015-00009
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2018,02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2018
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUALITY CONTROL MAS 1606