ARCHITECT C16000 SYSTEM 3L77-01 03L77-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for ARCHITECT C16000 SYSTEM 3L77-01 03L77-01 manufactured by Abbott Laboratories (irving Ia/cc).

MAUDE Entry Details

• Report Number: 3016438761-2020-00016
• MDR Report Key: 9890791
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-27
• Date of Report: 2020-03-27
• Date of Event: 2020-03-10
• Date Mfgr Received: 2020-03-10
• Device Manufacturer Date: 2011-09-11
• Date Added to Maude: 2020-03-27
• 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: CHRISTIAN LEE
• Manufacturer Street: 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
• Manufacturer City: ABBOTT PARK IL 600643537
• Manufacturer Country: US
• Manufacturer Postal: 600643537
• Manufacturer Phone: 224668-294
• Manufacturer G1: ABBOTT LABORATORIES (IRVING IA/CC)
• Manufacturer Street: 1915 HURD DRIVE
• Manufacturer City: IRVING TX 75038
• Manufacturer Country: US
• Manufacturer Postal Code: 75038
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARCHITECT C16000 SYSTEM
• Generic Name: AUTOMATED CHEMISTRY ANALYZER
• Product Code: JJE
• Date Received: 2020-03-27
• Model Number: 3L77-01
• Catalog Number: 03L77-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT LABORATORIES (IRVING IA/CC)
• Manufacturer Address: 1915 HURD DRIVE IRVING TX 75038 US 75038

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-27