CELLIENT PROCESSOR
Received May 17, 2018 · Event occurred Apr 18, 2018
Report 1222780-2018-00091 · MDR key 7523585
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED OBSERVED ABNORMAL CELLS THAT WERE NOT LOCATED IN THE 22 FOVS SELECTED BY THE IMAGER. CYTOLOGY APPLICATION SPECIALIST (CAS) REVIEWED SLIDE ON THE RSMP AS AN UNKNOWN MIXED WITH OTHER SLIDES. CASE PRESENTED HAD NO TRIGGERS IN THE 22 FOVS TO PROMPT AN AUTOSCAN. FULL REVIEW OF SLIDE DURING QC SHOWED ABNORMAL CELLS OUTSIDE THE FOVS. CAS REVIEWED THIS CASE AND DISCUSSED WITH LAB PERSONNEL. CAS AGREED THERE WERE NO CHANGES SEEN IN 22 FOV TO PROMPT AN AUTOSCAN. SINGLE SHEET OF LSIL IDENTIFIED OUTSIDE OF FOV. PLEASE COMMENT ON THE OVERALL APPEARANCE OF THE SLIDE: CELLULAR, WELL PREPARED SAMPLE. ABNORMAL CELLS WERE DISCOVERED BY THE LAB WHEN: THE CASE WAS DISCOVERED WHEN DOING 100% QC FOR NEW HIRE. LABORATORY'S INTERPRETATION OF CELLS OUTSIDE.