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

Field service engineers (fse) evaluated the four (4) analyzers at the customers' sites.The fses were able to replicate the error messages described in the reported events.The fses replaced solenoid valves and returned the g8 analyzers into operational status.Three (3) of the 4 solenoid valves were returned to the tosoh instrument service center for investigation (isc).In one (1) of the three (3) returned solenoid valves, isc was able to replicate the reported due to the solenoid valve not opening and closing properly.In two (2) of the three (3) returned solenoid valves, isc was not able to replicate the reported events.

Event Description

This report summarizes 4 malfunction events on the g8 analyzer.The review of these events indicated that the g8 analyzers experienced pressure error messages, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.These reports were received from various sources.The two (2) events involved patient samples with no indication of patient intervention or adverse health consequences due to the delayed reporting test results.None of these events necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health.

Manufacturer Narrative

For corrected data, please refer to section g5.Pma/510(k).Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the 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, tokyo 10586 23; JA 1058623
• MDR Report Key: 8552856
• MDR Text Key: 146090330
• Report Number: 8031673-2019-00132
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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: 06/29/2019
• Patient Sequence Number: 1