ATELLICA IM FOLATE (FOL) N/A 10995572

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 2019-09-30 for ATELLICA IM FOLATE (FOL) N/A 10995572 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

• Report Number: 1219913-2019-00169
• MDR Report Key: 9134972
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-09-30
• Date of Report: 2019-09-30
• Date of Event: 2019-09-10
• Date Mfgr Received: 2019-09-12
• Device Manufacturer Date: 2019-03-04
• Date Added to Maude: 2019-09-30
• 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. EIMAN SULIEMAN
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: E. WALPOLE MA 02032
• Manufacturer Country: US
• Manufacturer Postal: 02032
• Manufacturer Phone: 5086604603
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Manufacturer Street: 333 CONEY STREET
• Manufacturer City: E. 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: ATELLICA IM FOLATE (FOL)
• Generic Name: FOLATE IMMUNOASSAY
• Product Code: CGN
• Date Received: 2019-09-30
• Model Number: N/A
• Catalog Number: 10995572
• Lot Number: 289
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• 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		2019-09-30