MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 GX

Model Number GX

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The tosoh automated glycohemoglobin analyzer hlc-723 gx is not approved for use in the united states; however, it is a similar device to us-approved tosoh automated glycohemoglobin analyzer hlc-723g8.The tbi field service engineer (fse) instructed the distributor fse to reboot the analyzer, which resolved the issue.The analyzer was operating as expected.There was no further action required by fse.

Event Description

This report summarizes 1 malfunction event on the gx analyzer.The review of the event indicated that the gx analyzer experienced a software issues, which caused delayed reporting of critical patient results.This report is received from one 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 AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 GX
• Type of Device: GX
• 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: 8543680
• MDR Text Key: 142930923
• Report Number: 8031673-2019-00094
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GX
• Device Catalogue Number: 0023130
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1