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

A field service engineer (fse) evaluated the reported event at the customer's site.The fse was able to replicate the reported event.The fse resolved the issue by replacing the stator face, rotor seal, and sample loop.The g8 analyzer was returned into operational status.The stator face, rotor seal, and sample loop were returned to the tosoh instrument service center (isc) for investigation.Upon functional investigation of the returned parts the reported event could not be replicated by isc.This event was incorrectly filed under mfr report #8031673-2019-00138 on 30-apr-2019.This report corrects the manufacturer report number for this event.

Event Description

This report summarizes 1 malfunction event on the g8 analyzer.The review of this event indicated that the g8 analyzer experienced out of range quality controls, which caused delayed reporting of hemoglobin a1c (hba1c) patient results.This report was received from one (1) source.There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results.This event did not necessitate 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, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 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: 8857924
• MDR Text Key: 216611569
• Report Number: 8031673-2019-00179
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• 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