ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

SECTION E1 - FACILITY NAME: COMPLETE FACILITY NAME IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY I B12, LIST NUMBER 07P67-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P67-21/-31. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

A LITERATURE ARTICLE BY FRÍAS RUIZ, C., GARCIA CALCERRADA, I., HERNÁNDEZ CASTRO, R., GARCIA DE LA ROSA, G., DE LAS HERAS FLÓREZ, S., ¿TOWARD PRECISION DIAGNOSTICS: UNVEILING MACROVITAMIN B12 IN HYPERVITAMINOSIS CASES¿, CLINICA CHIMICA ACTA, SUPPLEMENT 1 558 ELSEVIER B.V. (MAY 1, 2024), DOCUMENTED FALSELY ELEVATED ALINITY I B12 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR 7 PATIENT SAMPLES. THE PATIENTS¿ VITAMIN B12 RESULTS WERE AROUND 1000 PG/ML. AN INTERFERENCE STUDY WAS CONDUCTED USING POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE PATIENTS WERE DETERMINED TO BE VITAMIN B12 DEFICIENT. THE FALSELY ELEVATED ALINITY I B12 RESULTS WERE DUE TO THE PRESENCE OF MACROVITAMIN B12. PER THE ALINITY I B12 PACKAGE INSERT, EXPECTED VALUE SECTION, THE EXPECTED RANGE IS 187 TO 883 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I B12 RESULT INCLUDED A REVIEW OF DATA AND INFORMATION FROM THE ARTICLE ¿TOWARD PRECISION DIAGNOSTICS: UNVEILING MACROVITAMIN B12 IN HYPERVITAMINOSIS CASES¿, TICKET TRENDING REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED IN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT COULD NOT BE PERFORMED AS THE LIKELY CAUSE LOT IS UNKNOWN. A REVIEW OF THE COMPLAINT TRENDING REPORT DID IDENTIFY TRENDS FOR LIST NUMBER 07P67; HOWEVER, NO RELATED TRENDS WERE IDENTIFIED RELATING TO THE COMPLAINT ISSUE UNDER REVIEW. THE OVERALL PERFORMANCE OF THE ALINITY I B12 ASSAY WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE REVIEW SHOWS THAT THE MEDIAN PATIENT RESULTS FOR ALL THE LOTS IN REVIEW ARE WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH HISTORICAL LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE ASSAY. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I B12 REAGENT, LOT UNKNOWN.

Description of Event or Problem

A LITERATURE ARTICLE BY FRÍAS RUIZ, C., GARCIA CALCERRADA, I., HERNÁNDEZ CASTRO, R., GARCIA DE LA ROSA, G., DE LAS HERAS FLÓREZ, S., ¿TOWARD PRECISION DIAGNOSTICS: UNVEILING MACROVITAMIN B12 IN HYPERVITAMINOSIS CASES¿, CLINICA CHIMICA ACTA, SUPPLEMENT 1 558 ELSEVIER B.V. (MAY 1, 2024), DOCUMENTED FALSELY ELEVATED ALINITY I B12 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR 7 PATIENT SAMPLES. THE PATIENTS¿ VITAMIN B12 RESULTS WERE AROUND 1000 PG/ML. AN INTERFERENCE STUDY WAS CONDUCTED USING POLYETHYLENE GLYCOL (PEG) PRECIPITATION AND THE PATIENTS WERE DETERMINED TO BE VITAMIN B12 DEFICIENT. THE FALSELY ELEVATED ALINITY I B12 RESULTS WERE DUE TO THE PRESENCE OF MACROVITAMIN B12. PER THE ALINITY I B12 PACKAGE INSERT, EXPECTED VALUE SECTION, THE EXPECTED RANGE IS 187 TO 883 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.