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 8 of the 9 injection valves on the g8 analyzers at the customers' sites.One event was evaluated by the fse over-the-phone with the customer.The fses were able to confirm the reported events.The 9 g8 analyzers were repaired by either adjustments, cleaning, or replacing the injection valves, and returned to operational status.Four (4) of the 7 injection valves were returned for investigation to the tosoh instrument service center (isc).The investigation by isc replicated the reported events on 2 of the 4 returned injection valves.

Event Description

This report summarizes 9 malfunction events on the g8 analyzer.The review of these events indicated that the g8 analyzers experienced injection valve failures, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.These reports were received from various sources.One of the 9 events involved patient samples with 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

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: 8552818
• MDR Text Key: 146474302
• Report Number: 8031673-2019-00124
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 9
• 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: 06/28/2019
• Patient Sequence Number: 1