ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I CA19-9XR RESULTS. SID (B)(6) GENERATED >1200.00 NG/ML, REPEATED <20.60, 6.95, 6.26 NG/ML. IT IS UNKNOWN IF THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER CHARACTER LIMIT WAS MAXED; THE FULL ID IS (B)(6). NO ADDITIONAL PATIENT INFORMATION AVAILABLE. SECTION E1 PHONE NUMBER CHARACTER LIMIT WAS MAXED, THE FULL PHONE IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-20/-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/-31, AND 510K/PMA/BLA OF K052000. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW AND LABELING REVIEW. NO RETURN SPECIMENS WERE PROVIDED BY THE CUSTOMER. A REVIEW WAS PERFORMED FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE. THE REVIEW OF THIS DATA DID NOT IDENTIFY INCREASED COMPLAINT ACTIVITY FOR COMPLAINT LOT OR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT ISSUE. HISTORICAL PERFORMANCE REVIEW OF REAGENT LOT 71454FP00 WAS EVALUATED USING WORLD WIDE DATA FOR ALINITY I CA 19-9XR ASSAY WITH NO UNUSUAL REAGENT LOT PERFORMANCE IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I CA19-9XR RESULTS. SID (B)(6) GENERATED >1200.00 NG/ML, REPEATED <20.60, 6.95, 6.26 NG/ML. IT IS UNKNOWN IF THE PATIENT HAS PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.