ADVIA AUTOSLIDE SYSTEM 10282177

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 2020-01-09 for ADVIA AUTOSLIDE SYSTEM 10282177 manufactured by Siemens Healthcare Diagnostics Inc..

MAUDE Entry Details

• Report Number: 2432235-2020-00010
• MDR Report Key: 9569061
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2020-01-09
• Date of Report: 2020-02-20
• Date of Event: 2019-12-19
• Date Mfgr Received: 2020-01-27
• Date Added to Maude: 2020-01-09
• 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: CHRISTOPHER AEBIG
• Manufacturer Street: 511 BENEDICT AVE
• Manufacturer City: TARRYTOWN, NY NY 10591
• Manufacturer Country: US
• Manufacturer Postal: 10591
• Manufacturer Phone: 9145242740
• Manufacturer G1: HORIBA MEDICAL, PARC EUROMEDICINE
• Manufacturer Street: REGISTRATION NUMBER: 300014887 RUE DU CHADUCEE - BP7290
• Manufacturer City: MONTPELLIER CEDEX 4, 34184
• Manufacturer Country: FR
• Manufacturer Postal Code: 34184
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADVIA AUTOSLIDE SYSTEM
• Generic Name: ADVIA AUTOSLIDE SYSTEM
• Product Code: GKL
• Date Received: 2020-01-09
• Model Number: ADVIA AUTOSLIDE SYSTEM
• Catalog Number: 10282177
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Address: 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-09