ARCHITECT HIV AG/AB COMBO 04J27-27

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-08 for ARCHITECT HIV AG/AB COMBO 04J27-27 manufactured by Abbott Gmbh.

MAUDE Entry Details

• Report Number: 3002809144-2020-00026
• MDR Report Key: 9565546
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-01-08
• Date of Report: 2020-01-22
• Date of Event: 2019-12-12
• Date Mfgr Received: 2020-01-22
• Device Manufacturer Date: 2019-11-06
• Date Added to Maude: 2020-01-08
• 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 GMBH
• Manufacturer Street: MAX-PLANCK-RING 2
• Manufacturer City: WIESBADEN 65205
• Manufacturer Country: GM
• Manufacturer Postal Code: 65205
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Generic Name: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Product Code: MZF
• Date Received: 2020-01-08
• Catalog Number: 04J27-27
• Lot Number: 09424BE00
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT GMBH
• Manufacturer Address: MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-01-08