ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 / 31, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR AND PROVIDED THE FOLLOWING DATA: EARLY MARCH: AUTOMATIC DILUTION WITH ALINITY WAS 2,200U/ML END OF MARCH: AUTOMATIC DILUTION WITH ALINITY: AROUND 1,500U/ML, GOOD REPRODUCIBILITY. OUTSOURCED: FUJIREBIO LUMIPULSE PLATFORM GENERATED A RESULT OF 15U/ML (NEGATIVE) THE CUSTOMER REPORTED LOTS 70427FP00 AND 68329FP00 WERE IMPACTED, HOWEVER DID NOT PROVIDE WHICH RESULTS CAME FROM WHICH LOT. ADDITIONAL LABORATORY AND PATIENT DATA: MEDICAL HISTORY/DIAGNOSIS: UNKNOWN. DUPAN-2: NEGATIVE CEA: NEGATIVE NORMAL DIAGNOSTIC IMAGING. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER PATIENT MEDICAL INFORMATION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. 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. DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ISSUES. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ALINITY I CA 19-9XR AND DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REVIEWED USING FIELD DATA FROM CUSTOMERS. THE REVIEW OF FIELD DATA DETERMINED THE MEDIAN PATIENT RESULTS FOR LOT 70427FP00 WAS WITHIN THE ESTABLISHED LIMITS. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR REAGENT LOT 70427FP00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR AND PROVIDED THE FOLLOWING DATA: EARLY (B)(6): AUTOMATIC DILUTION WITH ALINITY WAS 2,200U/ML. END OF (B)(6): AUTOMATIC DILUTION WITH ALINITY: AROUND 1,500U/ML, GOOD REPRODUCIBILITY. OUTSOURCED: FUJIREBIO LUMIPULSE PLATFORM GENERATED A RESULT OF 15U/ML (NEGATIVE) THE CUSTOMER REPORTED LOTS 70427FP00 AND 68329FP00 WERE IMPACTED, HOWEVER DID NOT PROVIDE WHICH RESULTS CAME FROM WHICH LOT. ADDITIONAL LABORATORY AND PATIENT DATA: MEDICAL HISTORY/DIAGNOSIS: UNKNOWN. DUPAN-2: NEGATIVE. CEA: NEGATIVE. NORMAL DIAGNOSTIC IMAGING. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER PATIENT MEDICAL INFORMATION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.