ARCHITECT BNP CONTROLS 08K28-12

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 2019-09-20 for ARCHITECT BNP CONTROLS 08K28-12 manufactured by Abbott Germany.

MAUDE Entry Details

• Report Number: 3002809144-2019-00568
• MDR Report Key: 9100659
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-09-20
• Date of Report: 2019-09-20
• Date Mfgr Received: 2019-09-04
• Device Manufacturer Date: 2018-09-05
• Date Added to Maude: 2019-09-20
• 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 GERMANY
• Manufacturer Street: MAX-PLANCK-RING 2
• Manufacturer City: WIESBADEN 65205
• Manufacturer Country: GM
• Manufacturer Postal Code: 65205
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Removal Correction Number: 3002809144-06/4/19-006R
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARCHITECT BNP CONTROLS
• Generic Name: BNP CONTROLS
• Product Code: JJX
• Date Received: 2019-09-20
• Catalog Number: 08K28-12
• Lot Number: 44K81118
• Device Expiration Date: 2019-09-05
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT GERMANY
• Manufacturer Address: MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-20