ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY N/A 10309058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-28 for ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY N/A 10309058 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

• Report Number: 1219913-2020-00083
• MDR Report Key: 9770905
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-02-28
• Date of Report: 2020-03-17
• Date of Event: 2020-02-04
• Date Mfgr Received: 2020-03-02
• Device Manufacturer Date: 2019-05-31
• Date Added to Maude: 2020-02-28
• 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: STEPHEN PERRY
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: EAST WALPOLE, MA
• Manufacturer Country: US
• Manufacturer Phone: 6604163
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: EAST WALPOLE, MA
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY
• Generic Name: HBSAG CONFIRMATORY IMMUNOASSAY
• Product Code: LOM
• Date Received: 2020-02-28
• Model Number: N/A
• Catalog Number: 10309058
• Lot Number: 408541511
• 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 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-28