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

Model Number G8

Device Problem Imprecision (1307)

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

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived onsite to address the reported event.Fse performed pm per the g8 analyzer checklist, which was successful in resolving the issue subsequent patient precision, calibration, and qc results were good and the customer prepared the qc material without issue.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).There were no similar complaints identified during the search period.The g8 operator's manual under chapter 3, assay operations, was reviewed: the 3.5 daily check: be sure to check the following items before starting an assay (start command).Check the calibration setting on the main screen (first screen), check the status of the calibration and the calib key display.Perform a calibration before actual sample testing.Use the tosoh hemoglobin a1c calibrator set to calibrate the analyzer.Other calibrators cannot be used.The assigned values for the calibrators differ for each lot.Input the new assigned value when you change lots.The assigned values in ngsp units are printed in the instructions for use and on the vial; the assigned values in ifcc units are printed only in the instructions for use.The lot number is printed on the calibrator box, instructions for use and vials.See "chapter 3 section 3.6: calibration" for information concerning input of calibration values.Check the column and filter count numbers column: the number shown on the main screen is the number of injections since the last column replacement.Replacement period: as needed refer to chapter 5, section 5.6: column replacement for instruction for replacement of the column.The hemoglobin a1c st aia-pack hba1c package insert states the following: quality control: in order to monitor and evaluate the precision of the analytical performance, it is recommended that aia-pack hba1c control set be assayed daily.The minimum recommendations for the frequency of running control material are: after calibration, controls are run in order to confirm the calibration curve.Controls should be run if certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).After daily maintenance, controls should be run in order to verify the overall performance of the tosoh aia system analyzer.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.The most probable cause of the reported event was due to the device requiring periodic maintenance.

Event Description

It was reported that biorad lot# 33960 level 2 quality control (qc), lot# 33960 was reporting higher than the mean, but still within two standard deviations (sd) on the customer's g8 analyzer.Technical support (ts) instructed the customer to recalibrate with fresh reagents, buffers and calibrators; however, the customer did not have any different reagent lots on site.Technical support (ts) instructed the customer to recalibrate with fresh reagents, buffers and calibrators; however, the customer did not have any different reagent lots on site.Ts sent the customer a new calibrator set and tosoh qc.The customer later called to request the service be schedule with periodic maintenance (pm) that had already been scheduled for the device.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.

• 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
• 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: 7750013
• MDR Text Key: 116718293
• Report Number: 8031673-2018-00751
• 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: Other
• Type of Report: Initial
• Report Date: 08/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2018
• 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: 08/04/2018
• Distributor Facility Aware Date: 07/20/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/04/2018
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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