ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

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 OF A RETAINED KIT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET TRENDING REVIEW BY LIST NUMBER DID NOT IDENTIFY ANY TRENDS REGARDING THE COMMONALITIES FOR THE LOT NUMBER AND COMPLAINT ISSUE. THE TICKET SEARCH BY LOT INDICATES THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF ALINITY I CMV IGG REAGENT LOT 61431FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ALINITY I CMV IGG REAGENT LOT 61431FZ00.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6), INITIAL CMV IGG RESULT = 85.5 AU/ML (REACTIVE); REPEAT RESULT = 0.6 AU/ML (NONREACTIVE). NO PREVIOUS CMV IGG. CMV IGM RESULT = NEGATIVE. REFERENCE RANGE: = 6.0 REACTIVE. NEGATIVE RESULT WAS REPORTED TO THE DOCTOR. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

A1 - PATIENT IDENTIFIER: THE COMPLETE PATIENT IDENTIFIER IS (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24/-33. 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 A FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6). INITIAL CMV IGG RESULT = 85.5 AU/ML (REACTIVE); REPEAT RESULT = 0.6 AU/ML (NONREACTIVE) NO PREVIOUS CMV IGG CMV IGM RESULT = NEGATIVE REFERENCE RANGE: = 6.0 REACTIVE NEGATIVE RESULT WAS REPORTED TO THE DOCTOR. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.