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

Model Number G8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/12/2015

Event Type  Injury  

Event Description

On (b)(6) 2015: tosoh was notified that a tech at an account had reported multiple pt results from the tosoh g8 with "check peaks" flags.These are considered non-reportable results.The results were then sent to the lab lis where they were again flagged but released by the tech with no corrective action taken prior to the release.Tosoh did not received any pt data but was only notified that incorrect results had been released.Root cause: operator error.

Event Description

On (b)(6) 2015, the customer called tosoh technical support to report receiving multiple patient results from the tosoh g8 analyzer with "check peaks" flags.The results were sent to the lab lis where they were again flagged but released by the technician with no corrective action taken prior to release.The customer indicated that this analyzer is used for pediatric hba1c results.The issue began around on (b)(6) 2015 and possibly 20 patient results may have been released that were not reportable.The customer indicated that an adjustment to the flow rate on (b)(6) 2015 resolved the problem, and that corrected reports have been issued.

Manufacturer Narrative

Mfr site: contact office: (b)(6).Manufacturing site: tosoh corporation (manufacturer), (b)(6).Date received by manufacturer: 18-may-2015.510k: k071132.Type or report: follow-up #: 1.Type of reportable event: malfunction.If follow-up, what type: correction.Device evaluated by mfr: yes.Patient codes: 3190 device codes: 1643, 2914, 2456 method: 36, 3323, 3372 results: 114, 180 conclusions: 19.Usage of device: reuse.The most probable cause of the check peaks flag is related to the flow rate as the customer indicated the retention time was 0.64-0.65.Ideal retention time for sa1c is approximately equal to 0.59.The customer adjusted the flow rate to 1.04.Review of the g8 variant analysis mode training manual informs the user of the following: the time it takes from injection of the sample to the time the specific peak elutes off the column is called the retention time.Each of the expected fractions has a window of acceptable retention times.As long as the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within the specified window, an unknown peak (p00) results.Each peak that elutes at a retention time that does not fall within the specified window is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the flow factor.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.

• 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: 4796007
• MDR Text Key: 5819172
• Report Number: 3005529799-2015-00007
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility,user facility
• 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: 05/20/2015
• Is this an Adverse Event Report?: Yes
• 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: 04/16/2018
• Distributor Facility Aware Date: 05/18/2015
• Device Age: 8 YR
• 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
• Patient Outcome(s): Other