THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT HE4 RESULT OF 33.2 PMOL/L WAS GENERATED FOR A PATIENT WITH A CA 125 RESULT OF 433.1 U/ML AND 3.6% ROMA (RISK OF OVARIAN MALIGNANCY ALGORITHM) ON (B)(6) 2015. THIS TESTING WAS PERFORMED BECAUSE A PELVIC MASS WAS FOUND IN THE PATIENT'S SONOGRAPHY REPORT. SURGERY WAS PERFORMED ON (B)(6) 2015 AND THE HISTOPATHOLOGICAL DIAGNOSIS REVEALED SERIOUS CARCINOMA OF THE OVARY. THE POST-SURGICAL ROMA WAS 49.8%. A POST-SURGICAL HE4 RESULT WAS NOT PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).
N
Patient 1
THIS FOLLOW-UP EMDR IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE. SUSPECT MEDICAL DEVICE. THE CORRECT PRODUCT CODE FOR THIS MEDICAL DEVICE, ARCHITECT (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETE.
N
Patient 1
REVIEW OF TICKET TRENDING AND LOT SEARCH DATA DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 42042M500. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS ACCURACY TESTING SHOWS THAT THE ASSAY PERFORMS PER SPECIFICATION. NO MALFUNCTION WAS IDENTIFIED SINCE THE ISSUE INVOLVES ONE DISCREET PATIENT AND THE SENSITIVITY FOR STRATIFYING PATIENTS WITH STAGE I-IV EPITHELIAL OVARIAN CANCER INTO THE HIGH RISK GROUP IS 93% AT A SPECIFICITY OF 75%. ADDITIONALLY, THE LIMITATIONS OF THE PROCEDURE AND EXPECTED VALUES SECTION OF THE ARCHITECT HE4 PACKAGE INSERT ADDRESSES THE CUSTOMER'S ISSUE.