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 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer's site to address the reported event.Fse confirmed the flag from error log but could not confirm the incorrect patient results.Fse reproduced the hb-var problem by running the patient's samples on analyzer 1.While troubleshooting, fse found the retention time (rt) was running high, and the small syringe was leaking.Fse replaced the small syringe and the check valves, the rt dropped from 0.61 to 0.56minutes.Fse adjusted the flow rate to achieve rt of 0.59 minutes, then primed the analyzer but the hb-var persisted.Fse decontaminated the analyzer and ran the analyzer until the hb-var was gone.Fse successfully completed precision, calibration and qc runs without error and within acceptable range.No further action required by field service.The g8 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no similar complaints identified during the search period.The g8 variant operator's manual chapter 1, introduction and application states: interpretation of results: the sa1c measuring range is 4.0 - 16.9%.The ideal retention time for sa1c is 0.59 minutes.The ideal retention time for a0 is 0.90minutes.The g8 variant operator's manual chapter 3, provides detailed information on test report interpretation and analyzer flag settings.The most probable cause of the reported event is due to faulty small syringe and check valves and biological contamination of the system.

Event Description

The customer reported discrepant patient results for hemoglobin a1c (hba1c) on the g8 analyzer.The samples were run with two g8 analyzers.Analyzer 1 result = hv peak flag.Analyzer 2 result = 4.1%.The results were reported to the physician and the physician questioned the result due to the patient's result history, which should be higher.The patient sample was sent to a reference lab and result was 9.3% which is what the physician expected.The patient was brought back in for a redraw and the new sample was run on both g8 analyzers after qc run.Analyzer 1 result = hv3 peak flag.Analyzer 2 result = 9.8%.A field service engineer (fse) was dispatched to the customer's site to further investigation.There was no indication of any patient intervention or adverse health consequences due to the reported 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, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10449495
• MDR Text Key: 234391978
• Report Number: 8031673-2020-00230
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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