TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 GX 0023130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-24 for TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 GX 0023130 manufactured by Tosoh Corporation.

Event Text Entries

[142930923] 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.
Patient Sequence No: 1, Text Type: N, H10

[142930924] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8031673-2019-00094
• MDR Report Key: 8543680
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-04-24
• Date of Report: 2019-04-24
• Date Added to Maude: 2019-04-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. DORIA ESQUIVEL
• Manufacturer Street: SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA
• Manufacturer City: MINATO-KU, TOKYO 1058623
• Manufacturer Country: JA
• Manufacturer Postal: 1058623
• Manufacturer G1: TOSOH CORPORATION
• Manufacturer Street: SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA
• Manufacturer City: MINATO-KU, TOKYO 1058623
• Manufacturer Country: JA
• Manufacturer Postal Code: 1058623
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 GX
• Generic Name: GX
• Product Code: LCP
• Date Received: 2019-04-24
• Model Number: GX
• Catalog Number: 0023130
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TOSOH CORPORATION
• Manufacturer Address: SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 1058623 JA 1058623

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-24