ARCHITECT B12 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED DOCTORS QUESTIONING FALSELY HIGH ARCHITECT VITAMIN B12 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE CUSTOMER STATED HIGH RESULTS OF > 2000 PG/ML WERE BEING GENERATED ACROSS 2 OF THEIR ANALYZERS. THE CUSTOMER SENT THE SAMPLES OUT TO ANOTHER LAB (REFERENCE LAB) AND THE B12 RESULT OF ONE SAMPLE CAME BACK AS 285 PG/ML. THE CUSTOMER¿S REFERENCE RANGE FOR B12 IS 213-816 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

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.

Additional Manufacturer Narrative

SECTION D4 EXPIRATION DATE AND PRIMARY UDI NUMBER WAS UPDATED. 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 IN-HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 62127UD00. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 62127UD00 AND COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH COMPLAINT LOT NUMBER 62127UD00. TESTING MET VALIDITY AND ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT VITAMIN B12 FOR LOT 21075UI01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED DOCTORS QUESTIONING FALSELY HIGH ARCHITECT VITAMIN B12 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE CUSTOMER STATED HIGH RESULTS OF 2000 PG/ML WERE BEING GENERATED ACROSS 2 OF THEIR ANALYZERS. THE CUSTOMER SENT THE SAMPLES OUT TO ANOTHER LAB (REFERENCE LAB) AND THE B12 RESULT OF ONE SAMPLE CAME BACK AS 285 PG/ML. THE CUSTOMER¿S REFERENCE RANGE FOR B12 IS 213-816 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.