ARCHITECT B12 REAGENT KIT

Additional Manufacturer Narrative

THE INITIAL REPORTER POSTAL CODE OF (B)(6) SHOULD BE (B)(6). A DIGIT OF 0 WAS ADDED TO ALIGN WITH FORM 5 DIGIT FORMAT. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE ACCOUNT OBSERVED FALSE ELEVATED ARCHITECT B12 THAT REPEATED LOWER. SID: (B)(6) (36 YEAR OLD PREGNANT PATIENT WITH HISTORY OF PET)) GENERATED 767.6, 1213.2, 106.0, 100.3, 89.7, 103.6, 96.8, 101.2, 82.1 PMOL/L. NO ADDITIONAL SPECIFIC PATIENT INFORMATION PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT 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 IN-HOUSE TESTING. 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 THE LIKELY LOT NUMBER 41672UD00 AND COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH COMPLAINT LOT NUMBER 41672UD00. 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 B12 REAGENT FOR LOT 41672UD00 WAS IDENTIFIED.