ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

UPDATED INFORMATION IN SECTION B5 AND SECTION H6 MEDICAL DEVICE PROBLEM CODE AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR A 29-YEAR-OLD MALE PATIENT IN THE DEPARTMENT OF GASTROENTEROLOGY WHO WAS CLINICALLY DIAGNOSED WITH PANCREATIC CANCER. (CUSTOMER PROVIDED REFERENCE RANGE OF <37 U/ML) SID (B)(6) INITIAL RESULT = >1200 U/ML, REPEAT RESULT WITH 1:10 DILUTION RESULT = 632.98, SECOND REPEAT WITH 1:10 DILUTION RESULT = 671.67 U/ML. SECOND SAMPLE FROM THE SAME PATIENT = >1200 U/ML, REPEAT WITH 1:10 DILUTION = OVER 600 U/ML (SPECIFIC RESULT NOT PROVIDED) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER IS QUESTIONING THE DECREASED RESULTS AS BEING INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR A 29-YEAR-OLD MALE PATIENT IN THE DEPARTMENT OF GASTROENTEROLOGY WHO WAS CLINICALLY DIAGNOSED WITH PANCREATIC CANCER. (CUSTOMER PROVIDED REFERENCE RANGE OF <37 U/ML) SID (B)(6), INITIAL RESULT = >1200 U/ML, REPEAT RESULT WITH 1:10 DILUTION RESULT = 632.98, SECOND REPEAT WITH 1:10 DILUTION RESULT = 671.67 U/ML. SECOND SAMPLE FROM THE SAME PATIENT = >1200 U/ML, REPEAT WITH 1:10 DILUTION = OVER 600 U/ML (SPECIFIC RESULT NOT PROVIDED) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER IS QUESTIONING THE DECREASED RESULTS AS BEING INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 76666FP00. IN HOUSE ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 76666FP00. AN INTERNAL CA 19-9XR PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR ASSAY FOR LOT 76666FP00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 WITH 510K/PMA/BLA NUMBER K052000 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS FOR A 29-YEAR-OLD MALE PATIENT IN THE DEPARTMENT OF GASTROENTEROLOGY WHO WAS CLINICALLY DIAGNOSED WITH PANCREATIC CANCER. (CUSTOMER PROVIDED REFERENCE RANGE OF <37 U/ML). SID (B)(6) INITIAL RESULT = >1200 U/ML, REPEAT RESULT WITH 1:10 DILUTION RESULT = 632.98, SECOND REPEAT WITH 1:10 DILUTION RESULT = 671.67 U/ML. SECOND SAMPLE FROM THE SAME PATIENT = >1200 U/ML, REPEAT WITH 1:10 DILUTION = OVER 600 U/ML (SPECIFIC RESULT NOT PROVIDED).. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.