CELLIENT

Description of Event or Problem

FALSE NEGATIVE ON IVDD: THE CUSTOMER REPORTED THERE WAS NO DIAGNOSTIC MATERIAL ON THE CELLIENT CELL BLOCKS. THE CUSTOMER HAS HAD 3 CASES (2 PLEURAL FLUIDS AND 1 LYMPH NODE FNA) THAT WERE MALIGNANT ON TRADITIONAL CELL BLOCK AND THE THINPREP NON GYN (TPNG) SLIDE BUT THE CELLIENT BLOCKS JUST HAD INFLAMMATION. THE CUSTOMER SPLIT THE SAMPLES FROM THE FRESH SPECIMEN, PROCESSED ACCORDING TO RECOMMENDED PROTOCOL, ADDED THE APPROPRIATE SPECIMEN TO THE TPNG VIAL AS WELL AS MADE A CONCURRENT CELLIENT VIAL. THE TPNG SLIDES WERE DIAGNOSTIC ON ALL 3 SPECIMENS, THE FNA AND ONE OF THE PLEURAL FLUIDS WERE MALIGNANT AND THE OTHER PLEURAL FLUID WAS DIAGNOSED AS SUSPICIOUS. THE LAB PROCESSED TRADITIONAL CELL BLOCKS USING HISTOGEL AS WELL AS CELLIENT. ALL 3 OF THE TRADITIONAL BLOCKS WERE DIAGNOSED THE SAME AS THE TPNG, HOWEVER, THE CELLIENT BLOCKS DID NOT HAVE ANY DIAGNOSTIC MATERIAL. THE LAB REPROCESSED THE MALIGNANT FLUID USING THE RESIDUAL MATERIAL IN THE CELLIENT VIAL AND THE RESIDUAL MATERIAL FROM THE TP VIAL AND THERE WERE STILL NO DIAGNOSTIC CELLS ON THE 2ND CELLIENT BLOCK. THE HOLOGIC CLINICAL APPLICATION SPECIALIST MICROSCOPICALLY REVIEWED THE 3 CASES WITH THE CUSTOMER AND CONFIRMED THE APPEARANCE OF THE SLIDES. THE CUSTOMER WAS OBSERVING PROPER PREP PROTOCOL USING THE THINPREP 2000 OPERATOR'S MANUAL AND THE QUICK REFERENCE GUIDES AND RECOMMENDED PROTOCOL FOR TPNG AND CELLIENT.

Additional Manufacturer Narrative

DEVICE IS BEING EVALUATED. ADD'L INFO WILL BE SUBMITTED AS RELEVANT.