ADVIA CENTAUR XP CA 125II N/A 10310443

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for ADVIA CENTAUR XP CA 125II N/A 10310443 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

• Report Number: 1219913-2019-00062
• MDR Report Key: 8551888
• Date Received: 2019-04-25
• Date of Report: 2019-07-26
• Date of Event: 2019-03-27
• Date Mfgr Received: 2019-06-28
• Device Manufacturer Date: 2018-06-28
• 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: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: LOUISE MCLAUGHLIN
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: EAST WALPOLE MA 02032
• Manufacturer Country: US
• Manufacturer Postal: 02032
• Manufacturer Phone: 5086604381
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: EAST WALPOLE MA 02032
• Manufacturer Country: US
• Manufacturer Postal Code: 02032
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ADVIA CENTAUR XP CA 125II
• Generic Name: CA 125II IMMUNOASSAY
• Product Code: LTK
• Date Received: 2019-04-25
• Model Number: N/A
• Catalog Number: 10310443
• Lot Number: 7711181
• Device Expiration Date: 2019-06-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Manufacturer Address: 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-25