TOSOH HLC-723G8 ANALYZER G8 021560

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 2019-04-25 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.

Event Text Entries

[146474198] A field service engineer (fse) evaluated 1 of the 2 printers on the g8 analyzers at the customer's site. The fse replaced the printer to resolve the issue. The printer was returned to the tosoh instrument service center (isc) for investigation. Isc was not able to replicate the reported event. In the 2nd event, the fse followed-up with the customer over-the-phone to address the reported event. The fse was able to replicate the error message over-the-phone with the customer. The issue was addressed by cleaning the printer on the g8 analyzer. The g8 analyzers were returned into operational status.
Patient Sequence No: 1, Text Type: N, H10

[146474199] This report summarizes 2 malfunction events on the g8 analyzer. The review of these events indicated that the g8 analyzers experienced printer error messages, which caused delayed reporting of hemoglobin a1c (hba1c) patient results. This report was received from 2 different sources. 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: 8031673-2019-00127
• MDR Report Key: 8552834
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-04-25
• Date of Report: 2019-07-02
• Date Mfgr Received: 2019-07-02
• Date Added to Maude: 2019-04-25
• 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 HLC-723G8 ANALYZER G8
• Generic Name: G8
• Product Code: LCP
• Date Received: 2019-04-25
• Model Number: G8
• Catalog Number: 021560
• Device Availability: Y
• Device Age: DA
• 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		2019-04-25