ARCHITECT B12 REAGENT KIT

Additional Manufacturer Narrative

ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 ARCHITECT B12 RESULT FOR ONE PATIENT WHEN RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL B12 RESULT = 480 PG/ML; REPEAT B12 RESULTS = 265 AND 256 PG/ML THE CUSTOMER'S PROCEDURE IS TO REPEAT SAMPLES W/ RESULTS > 315 PG/ML (NORMAL REFERENCE RANGE IS 300-2000 PG/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED AND SUPPORTS THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 50548UD00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. TESTING MET ACCEPTANCE AND VALIDITY CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER¿S ISSUE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PACKAGE INSERT, HETEROPHILIC ANTIBODIES AND RHEUMATOID FACTOR (RF) IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. 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. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT B12 ASSAY, REAGENT LOT 50548UD00, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT B12 RESULT FOR ONE PATIENT WHEN RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL B12 RESULT = 480 PG/ML; REPEAT B12 RESULTS = 265 AND 256 PG/ML. THE CUSTOMER'S PROCEDURE IS TO REPEAT SAMPLES W/ RESULTS > 315 PG/ML (NORMAL REFERENCE RANGE IS 300-2000 PG/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.