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 2 of the 4 syringe units on the g8 analyzers at the customers' sites.Two (2) of the 4 events were evaluated over-the-phone with the customer.The fses were able to confirm the reported events.The fses cleaned/lubricated the syringe units to address the reported event.The g8 analyzers were returned to operational status.

Event Description

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

Manufacturer Narrative

H3 device evaluation by manufacturer: for one (1) of the four (4) events, the syringe unit (large syrine) was returned to the instrument service center for evaluation.Visual inspection confirmed excessive corrosion/wear on plunger and barrel.No functional testing was performed due to the observed anomalies.The reported event was confirmed.The most probable cause of the reported event was due to a faulty syringe unit.

Manufacturer Narrative

Corrected data: for corrected data, please refer to 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: 8552850
• MDR Text Key: 145947875
• Report Number: 8031673-2019-00134
• 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,Followup
• Report Date: 08/09/2019

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