ARCHITECT CA 125 II 02K45-39

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 2019-06-17 for ARCHITECT CA 125 II 02K45-39 manufactured by Abbott Germany.

MAUDE Entry Details

• Report Number: 3002809144-2019-00325
• MDR Report Key: 8706156
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-06-17
• Date of Report: 2019-07-17
• Date of Event: 2019-05-14
• Date Mfgr Received: 2019-07-02
• Device Manufacturer Date: 2018-11-01
• Date Added to Maude: 2019-06-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• 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: NOEMI ROMERO-KONDOS, RN BSN
• Manufacturer Street: 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
• Manufacturer City: ABBOTT PARK IL 600643537
• Manufacturer Country: US
• Manufacturer Postal: 600643537
• Manufacturer Phone: 224667-512
• Manufacturer G1: ABBOTT GERMANY
• 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 CA 125 II
• Generic Name: OC 125 DEFINED ANTIGEN
• Product Code: LTK
• Date Received: 2019-06-17
• Catalog Number: 02K45-39
• Lot Number: 92024M800
• Device Expiration Date: 2019-07-26
• 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 GERMANY
• Manufacturer Address: MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-17