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

[146474302] Field service engineers (fse) evaluated 8 of the 9 injection valves on the g8 analyzers at the customers' sites. One event was evaluated by the fse over-the-phone with the customer. The fses were able to confirm the reported events. The 9 g8 analyzers were repaired by either adjustments, cleaning, or replacing the injection valves, and returned to operational status. Four (4) of the 7 injection valves were returned for investigation to the tosoh instrument service center (isc). The investigation by isc replicated the reported events on 2 of the 4 returned injection valves.
Patient Sequence No: 1, Text Type: N, H10

[146474303] This report summarizes 9 malfunction events on the g8 analyzer. The review of these events indicated that the g8 analyzers experienced injection valve failures, which caused delayed reporting of hemoglobin a1c (hba1c) patient results. These reports were received from various sources. One of the 9 events involved patient samples with no indication of patient intervention or adverse health consequences due to the delayed reporting of test results. None of these events necessitated 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: 8031673-2019-00124
• MDR Report Key: 8552818
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-04-25
• Date of Report: 2019-07-02
• Date Mfgr Received: 2019-06-28
• 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