ADVIA CENTAUR XP CA 19-9 N/A 10491379

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-21 for ADVIA CENTAUR XP CA 19-9 N/A 10491379 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

• Report Number: 1219913-2020-00023
• MDR Report Key: 9612373
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2020-01-21
• Date of Report: 2020-01-21
• Date of Event: 2019-12-18
• Date Mfgr Received: 2020-01-03
• Device Manufacturer Date: 2019-07-02
• Date Added to Maude: 2020-01-21
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. STACY LOUKOS
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: EAST WALPOLE MA 02032
• Manufacturer Country: US
• Manufacturer Postal: 02032
• Manufacturer Phone: 5086608576
• 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
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADVIA CENTAUR XP CA 19-9
• Generic Name: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Product Code: NIG
• Date Received: 2020-01-21
• Model Number: N/A
• Catalog Number: 10491379
• Lot Number: 052452
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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 105915097 US 105915097

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-21