D
Patient 1
THE ISSUE REPORTED VIA A 04/26/2012 MEDWATCH FORM WAS ABNORMAL CELLS MISSED BY THIN PREP IMAGER SYSTEM (I.E. ABNORMAL CELLS NOT PRESENT IN THE 22 FIELDS OF VIEW (FOV) PRESENTED). THE ROOT CAUSES DERIVED FROM PAST INVESTIGATIONS OF REPORTED ABNORMAL CELLS NOT PRESENT IN THE 22 FOVS FALL MAINLY INTO TWO CATEGORIES: RARE EVENT - AN EVENT IN WHICH THE SLIDE FALLS INTO THE CATEGORY WHERE THE CELLS IN QUESTION WOULD MATCH OUR EXPERIENCE IN THE CLINICAL TRIAL AS EVIDENCED IN TABLE 8 OF THE THINPREP IMAGING SYSTEM OPERATION SUMMARY AND CLINICAL INFO. CUSTOMER MISS - DETERMINED BY A HOLOGIC CYTOLOGY APPLICATIONS SPECIALIST (CAS) WHO IN A BLINDED MANNER MICROSCOPICALLY REVIEWS THE SLIDE(S) IN QUESTION AT THE LABORATORY. THE CAS IDENTIFIES ABNORMAL CELLS (TRIGGER CELLS) IN THE ORIGINAL IDENTIFIES ABNORMAL CELLS (TRIGGER CELLS) IN THE ORIGINAL 22 FOVS WHICH SHOULD HAVE PROMPTED A FULL SCAN REVIEW. THE ROOT CAUSE IS DETERMINED TO BE THE RESULT OF DIAGNOSTIC MISINTERPRETATION AND NOT RELATED TO THE FUNCTION / PERFORMANCE OF THE THINPREP IMAGER. CUSTOMER AND INSTRUMENT INFO WERE NOT INCLUDED ON MEDWATCH FORM. THERE IS NO INFO ON PT DIAGNOSIS, NOR A DELAY IN DIAGNOSIS. IF FURTHER INFO BECOMES AVAILABLE, A SEPARATE COMPLAINT WILL BE OPENED.