OtherNQN
FOCAL POINT
Received Feb 9, 2006 · Event occurred Dec 23, 2005
Report 1062336-2006-00001 · MDR key 672954
Device
Generic name
Automated Cervical Cytology Screener
Manufacturer
Tripath Imaging, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
*
- Cervical Changes
Narrative
Description of Event or Problem
CERVICAL CYTOLOGY PATIENT SAMPLE WAS EVALUATED BY FOCAL POINT PLATFORM IN 2003. MACHINE INDICATED THAT THE SLIDE /SMEAR NEEDED NO FURTHER REVIEW. THE SLIDE WAS RE-EVALUATED, DURING A 5 YEAR RETROSPECTIVE REVIEW OF SLIDES FOR THIS PATIENT THAT WAS PROMPTED, BECAUSE A MORE RECENT SLIDE FROM 2005 INDICATED ABNORMAL CELLS. THE REVIEW OF THE EARLIER SLIDE BY THE PATIENT'S PHYSICIAN INDICATED ABNORMAL CELLS (HSIL) NOTIFICATION OF THIS REPORT WAS RECEIVED ON JANUARY 9,2006.