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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated 1 of the 2 printers on the g8 analyzers at the customer's site.The fse replaced the printer to resolve the issue.The printer was returned to the tosoh instrument service center (isc) for investigation.Isc was not able to replicate the reported event.In the 2nd event, the fse followed-up with the customer over-the-phone to address the reported event.The fse was able to replicate the error message over-the-phone with the customer.The issue was addressed by cleaning the printer on the g8 analyzer.The g8 analyzers were returned into operational status.

Event Description

This report summarizes 2 malfunction events on the g8 analyzer.The review of these events indicated that the g8 analyzers experienced printer error messages, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.This report was received from 2 different sources.There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results.This event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.

Manufacturer Narrative

H.11 corrected data: for corrected data, please refer to section g.5.Pma/510(k).

• 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: 8552834
• MDR Text Key: 146474198
• Report Number: 8031673-2019-00127
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2019
• Patient Sequence Number: 1