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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

A complaint history review and service history review for similar complaints was performed for hba1c calibrator lot zs7001 from the 20th of march 2017 through awareness date on (b)(6) 2018.There were no similar complaints identified during the searched period.A complaint history review and service history review for similar complaints was performed for serial (b)(4) from the 20th of march 2017 through awareness date on (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 3, assay operations, under section 3.6 calibration states the following: we recommend calibrating the analyzer once a week.The laboratory may establish a longer calibration interval based on daily qc results.Be sure to calibrate in the following situations.If drift in qc is noted- the tosoh automated glycohemoglobin analyzer hlc-723g8 is a very precise instrument and you will note that the qc remains the same day after day.If there is a drift in qc values, it is necessary to recalibrate.When control values assayed are out of range calibrate when the control assay value falls outside the qc range.Measure the control sample again to confirm that it falls within the qc range before assaying a patient sample.After column replacement -calibrate after a new column has been installed.After analyzer maintenance - calibrate after periodic maintenance or repair.When an assay condition is being modified - calibrate when a parameter value (such as the flow factor) is being changed on the analyzer.The most probable cause of the reported issue was due to calibrators.(b)(4).

Event Description

The customer reported receiving calibration errors after installing a new column.The customer is using calibrator lot zs7001.Calibrator # 1 is recovering at 4.4 and its expected recovery per the calibrator insert to be 4.7.A new calibrator lot was ordered and shipped to the customer.On the 25th of april 2018 the customer called back and indicated that the new calibrators calibrated the instrument without any errors.Also, all of the quality controls results were normal and within specification.The instrument is functioning as intended and no further action is required.The reported error resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.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
• 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: 7525176
• MDR Text Key: 109365155
• Report Number: 8031673-2018-00419
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Distributor Facility Aware Date: 04/20/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/18/2018
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2010
• 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