ALINITY I B12 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 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07P67, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 66522UD00 WAS NOT IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I B12 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 66522UD00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT LOT 66522UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I B12 AND PROVIDED THE FOLLOWING DATA: THE RESULT WAS 1,466.9 PMOL/L. ANOTHER SPECIMEN TUBE WAS TESTED, AND THE RESULT WAS 213.4 PMOL/L. THE INITIAL SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 192.7 PMOL/L. THE SECOND SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 195.0 PMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31 WITH 510K/PMA/BLA NUMBER K121314. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I B12 AND PROVIDED THE FOLLOWING DATA: THE RESULT WAS 1,466.9 PMOL/L. ANOTHER SPECIMEN TUBE WAS TESTED, AND THE RESULT WAS 213.4 PMOL/L. THE INITIAL SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 192.7 PMOL/L. THE SECOND SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 195.0 PMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.