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 17 of the 23 events at the customers' sites.Two of the 23 events were evaluated by the fses over-the-phone with the customers.Four (4) of the 23 events were evaluated by technical support (ts) over-the-phone with the customers.Evaluation of 22 of the 23 events determined that the sampling unit assemblies on the g8 analyzers either required replacement, cleaning or lubrication to resolve the reported events.One (1) of the 23 events could not be replicated by the fse while at the customer's site.Two (2) sample units were returned to the tosoh instrument service center (isc) for investigation.Isc was not able to replicate the reported events.The g8 analyzers were repaired and returned to operational status.

Event Description

This report summarizes 23 malfunction events on the g8 analyzer.The review of these events indicated that the g8 analyzers experienced syringe failures, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.These reports were received from various sources.Of the 23 events, 4 events involved patient samples with no indication of patient intervention or adverse health consequences due to the delayed reporting in patient test results.None of these events necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health.

Manufacturer Narrative

This is a correction to the report submitted to the agency on 09-jun-2019, which should had read as follow: a 3rd sampling unit assembly was returned to the tosoh instrument service center (isc) for investigation.Isc was able to replicate the reported event.During functional testing the motor of the sampling unit assembly locked up, causing the reported syringe failure.The most probable cause of the reported event was due to a faulty sampling unit assembly.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

A 3rd sample unit was returned to the tosoh instrument service center (isc) for investigation.Isc was able to replicate the reported events.

Manufacturer Narrative

H.11 corrected data: for corrected data, please refer to section g.5.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: 8552835
• MDR Text Key: 146499262
• Report Number: 8031673-2019-00130
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 23
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,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: 06/30/2019
• Patient Sequence Number: 1