APTIMA * 501942 REV B.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-03 for APTIMA * 501942 REV B. manufactured by Gen-probe, Inc..

MAUDE Entry Details

• Report Number: 3363980
• MDR Report Key: 3363980
• Date Received: 2013-09-03
• Date of Report: 2013-09-03
• Date of Event: 2013-08-30
• Report Date: 2013-09-03
• Date Reported to FDA: 2013-09-03
• Date Reported to Mfgr: 2013-09-24
• Date Added to Maude: 2013-09-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: APTIMA
• Generic Name: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
• Product Code: MKZ
• Date Received: 2013-09-03
• Model Number: *
• Catalog Number: 501942 REV B.
• Lot Number: 610515A
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GEN-PROBE, INC.
• Manufacturer Address: 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-09-03