DIMENSION? EXL 200 DIMENSION? EXL 200 SYSTEM SMN 10636929

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 2020-03-26 for DIMENSION? EXL 200 DIMENSION? EXL 200 SYSTEM SMN 10636929 manufactured by Siemens Healthcare Diagnostics Inc.

MAUDE Entry Details

• Report Number: 2517506-2020-00120
• MDR Report Key: 9886141
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-26
• Date of Report: 2020-03-26
• Date of Event: 2020-03-10
• Date Mfgr Received: 2020-03-12
• Device Manufacturer Date: 2019-07-23
• Date Added to Maude: 2020-03-26
• 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: JAMES MORGERA
• Manufacturer Street: 500 GBC DRIVE PO BOX 6101
• Manufacturer City: NEWARK, DE
• Manufacturer Country: US
• Manufacturer Phone: 6318356
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS INC.-FLANDERS
• Manufacturer Street: REGISTRATION NUMBER 2247117 62 FLANDERS BARTLEY ROAD
• Manufacturer City: FLANDERS, NJ
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DIMENSION? EXL 200
• Generic Name: DIMENSION? EXL? 200 INTEGRATED CHEMISTRY SYSTEM
• Product Code: JJE
• Date Received: 2020-03-26
• Model Number: DIMENSION? EXL 200 SYSTEM
• Catalog Number: SMN 10636929
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
• Manufacturer Address: 500 GBC DRIVE PO BOX 6101 NEWARK, DE US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-26