ALINITY I B12 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT RESULTS FOR ALINITY I B12 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 187-883 PG/ML): (B)(6) 2024, SID (B)(6), INITIAL RESULT= 167 PG/ML; REPEAT RESULTS= 406 PG/ML AND 253 PG/ML (B)(6) 2024, SID (B)(6), INITIAL RESULT 184 PG/ML; REPEAT RESULT= 311 PG/ML THE CUSTOMER REPORTED OUT THE INITIAL RESULTS, WHICH WERE CONSIDERED TO BE CORRECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 /31. 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

UPDATED ENTRY FOR SECTION B5 - DESCRIBE EVENT OR PROBLEM, DATE CORRECTED FROM 17JUN224 TO 17JUN2024. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 60281UD00. TRENDING REVIEW DID IDENTIFY TRENDS FOR LIST NUMBER 07P67, HOWEVER, NO RELATED TRENDS WERE IDENTIFIED REGARDING COMMONALITIES FOR LOT NUMBER 60281UD00 AND ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 60281UD00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I B12 WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 60281UD00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT LOT NUMBER 60281UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT RESULTS FOR ALINITY I B12 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 187-883 PG/ML): (B)(6) 2024, SID (B)(6), INITIAL RESULT= 167 PG/ML; REPEAT RESULTS= 406 PG/ML AND 253 PG/ML. (B)(6) 2024, SID (B)(6), INITIAL RESULT 184 PG/ML; REPEAT RESULT= 311 PG/ML. THE CUSTOMER REPORTED OUT THE INITIAL RESULTS, WHICH WERE CONSIDERED TO BE CORRECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.