MAUDE Adverse Event Report: TOSOH CORPORATION G8

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the analyzer at the customer's site.Fse resoled the issue by replacing the flow cell.The analyzer was operational.No further action was required by fse.The replaced part was returned and received at the site on 02-apr-2019.

Event Description

This report summarizes 1 malfunction event on the g8 analyzer.The review of the event indicated that the g8 analyzer experienced a peak pattern error message, which caused delayed reporting of critical patient test results.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

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.The flow cell unit was returned to the instrument service center for evaluation of this event.Functional testing was performed on the part by performing precision testing with whole blood samples in an effort to duplicate the errors.The results of the testing were acceptable.The error could not be replicated.The part passed testing.The most probable cause of the reported event could not be determined.The part passed testing.Corrected data: h6 evaluation codes: 213-no device problem found 4315- cause not established.

• Brand Name: G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• MDR Report Key: 8552995
• MDR Text Key: 145775970
• Report Number: 8031673-2019-00056
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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
• Patient Sequence Number: 1