ARCHITECT TOTAL PSA 07K70-25

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 2020-02-21 for ARCHITECT TOTAL PSA 07K70-25 manufactured by Abbott Ireland Diagnostics Division.

MAUDE Entry Details

• Report Number: 3008344661-2020-00018
• MDR Report Key: 9738997
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-02-21
• Date of Report: 2020-03-04
• Date of Event: 2020-01-21
• Date Mfgr Received: 2020-03-03
• Device Manufacturer Date: 2019-05-16
• Date Added to Maude: 2020-02-21
• 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: 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 IRELAND DIAGNOSTICS DIVISION
• Manufacturer Street: FINISKLIN BUSINESS PARK DIAGNOSTICS DIVISION
• Manufacturer City: SLIGO NA
• Manufacturer Country: EI
• Manufacturer Postal Code: NA
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARCHITECT TOTAL PSA
• Generic Name: TOTAL PSA
• Product Code: LTJ
• Date Received: 2020-02-21
• Catalog Number: 07K70-25
• Lot Number: 03330FN00
• 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 IRELAND DIAGNOSTICS DIVISION
• Manufacturer Address: FINISKLIN BUSINESS PARK DIAGNOSTICS DIVISION SLIGO NA EI NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-21