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 waste system on the g8 analyzers at the customers' sites.The fses were able to replicate the reported events.The fses either cleaned or replaced the waste system and re-routed tubings to address the reported events.One (1) of the three (3) waste systems was returned for investigation to the tosoh instrument service center (isc).Isc was able to replicate the reported event.

Event Description

This report summarizes 3 malfunction events on the g8 analyzer.The review of these events indicated that the g8 analyzers experienced waste system error messages, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.These reports were received from various sources.One of the three (3) events one (1) 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.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 8552853
• MDR Text Key: 145776996
• Report Number: 8031673-2019-00135
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/25/2019

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
• Type of Device Usage: N
• Patient Sequence Number: 1