ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I B12 RESULTS 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 FOR THE COMPLAINT LOT. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE PRODUCT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. DEVICE HISTORY RECORD REVIEW ON LOT NUMBER 10291UI00 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. THE OVERALL PERFORMANCE OF ALINITY I B12 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED VIA ABBOTTLINK FROM CUSTOMERS WORLDWIDE AND SUGGESTED THAT THE PERFORMANCE IS ACCEPTABLE. ABBOTT DOES NOT HAVE A CORRELATION TO COMPETITOR ASSAY(S) CLAIM FOR ALINITY I B12. ASSAYS CAN PERFORM DIFFERENTLY BASED ON THE TYPE OF ANTIBODY/ANTIGEN USED, METHODOLOGY, INSTRUMENT VARIATION, STANDARDIZATION SOURCE, ASSAY TIME, ETC. AS PER PRODUCT LABELING, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, AND CLINICAL IMPRESSIONS. IF THE B12 RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS RECOMMENDED TO CONFIRM THE RESULT. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 ASSAY WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I B12, LOT NUMBER 10291UI00, WAS IDENTIFIED.

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 07P67-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P67-21.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE IS 187-883 PG/ML): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 273 PG/ML, WHICH THE PHYSICIAN QUESTIONED AND REQUESTED THAT IT BE REPEATED IN A DIFFERENT LAB ON A ROCHE ANALYZER, WHERE THE RESULT WAS 173 PG/ML, ROCHE REFERENCE RANGE IS 232-1245 PG/ML. THE PATIENT WAS THEN RETESTED ON (B)(6) 2020 AND THE RESULT WAS 276 PG/ML, WHICH THE PHYSICIAN QUESTIONED AND REQUESTED THAT IT BE REPEATED IN A DIFFERENT LAB ON A SIEMENS ANALYZER, WHERE THE RESULT WAS 154 PG/ML, SIEMENS REFERENCE RANGE IS 211-911 PG/ML. IT WAS NOTED THAT THE CUSTOMER RAN 10 MORE SPECIMENS ON THEIR ALINITY I AND COMPARED THE RESULTS WITH ROCHE AND SIEMENS TESTING AND FOUND THE ALINITY I RESULTS TO BE HIGHER, HOWEVER, THOSE RESULTS WERE NOT PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.