MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. 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 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

The distributor field service engineer (fse) arrived at the site to address the reported event.The fse decontaminated the g8 analyzer.The fse then replaced the reagents, column, and adjusted the flow rate.No further action was required.The g8 analyzer was performing within specifications.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 17nov2017 through 17dec2018.There were no similar complaints identified during the search period.The hemoglobin st aia-pack 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 g8 operator's manual chapter under chapter 8 - troubleshooting, states the following: adjusting the flow rate - how and why on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause of the reported event was due to flow rate adjustment was required.

Event Description

It was reported that the customer received high hemoglobin values and quality control (qc) out of range with their g8 analyzer.The analyzer was down.The distributor field service engineer was dispatched to address the reported event, which resulted in a 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 BIOSCIENCE, INC.; 3600 gatz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, IC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco,
• MDR Report Key: 8255544
• MDR Text Key: 134751525
• Report Number: 3005529799-2019-00011
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• 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: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/16/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2012
• 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