ALINITY I B12 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT WAS <148 PG/ML, REPEAT = 388.7 PG/ML. SID (B)(6) INITIAL RESULT WAS <148 PG/ML, REPEAT = 242.8 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

PATIENT IDENTIFIER: SIDS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21/-31.

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, AND 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 35473UD00AND COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH COMPLAINT LOT NUMBER 35473UD00. 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 ALINITY I B12 REAGENT FOR LOT 35473UD00 WAS IDENTIFIED.THIS FOLLOW UP INCLUDES A CORRECTION TO INCLUDE THE CODES IN SECTION H6 FOR COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS THAT WERE NOT INCLUDED IN THE INITIAL REPORT. SECTION D. EMAIL WAS UPDATED TO THE CURRENT CONTACT.