ALINITY I CA 19-9XR REAGENT KIT

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 OF A RETAINED REAGENT KIT LOT 69363FP00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE REPORTED EVENT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 69363FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR A 75-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH A PANCREATIC CANCER. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6): INITIAL RESULT WAS >1200.00 U/ML, REPEAT WAS >1200.00 U/ML, REPEATS WITH 1:10 DILUTION = 493.20 U/ML AND 484.51 U/ML. REFERENCE LABORATORY RESULTS: INITIAL RESULT WAS >1200.00 U/ML, REPEAT WITH AUTOMATIC DILUTION = 521.65 U/ML. DILUTION LINEARITY TEST = POOR DILUTION LINEARITY NEURAMINIDASE TREATMENT = SIGNIFICANT DECREASE IN THE MEASUREMENT VALUE WAS OBSERVED NONSPECIFIC BINDING ABSORPTION TEST = A DECREASE IN THE MEASUREMENT VALUE WAS OBSERVED HETEROPHILIC ANTIBODY BLOCKER TUBE (HBT) = A SLIGHT DECREASE IN THE MEASUREMENT VALUE WAS OBSERVED NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA19-9XR RESULT FOR A 75-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH A PANCREATIC CANCER. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6): INITIAL RESULT WAS >1200.00 U/ML, REPEAT WAS >1200.00 U/ML, REPEATS WITH 1:10 DILUTION = 493.20 U/ML AND 484.51 U/ML. REFERENCE LABORATORY RESULTS: INITIAL RESULT WAS >1200.00 U/ML, REPEAT WITH AUTOMATIC DILUTION = 521.65 U/ML. DILUTION LINEARITY TEST = POOR DILUTION LINEARITY. NEURAMINIDASE TREATMENT = SIGNIFICANT DECREASE IN THE MEASUREMENT VALUE WAS OBSERVED NONSPECIFIC BINDING ABSORPTION TEST = A DECREASE IN THE MEASUREMENT VALUE WAS OBSERVED HETEROPHILIC ANTIBODY BLOCKER TUBE (HBT) = A SLIGHT DECREASE IN THE MEASUREMENT VALUE WAS OBSERVED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/-31, WITH 510K/PMA/BLA NUMBER K052000.