ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3016438761-2025-00299 UNDER A DIFFERENT SUSPECT DEVICE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS THE SAME PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 7.8 AU/ML (REACTIVE). REPEAT RESULTS = 1.2 AU/ML (NONREACTIVE) AND 1.2 AU/ML (NONREACTIVE). PER THE ALINITY I CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 7.8 AU/ML (REACTIVE), REPEAT RESULTS = 1.2 AU/ML (NONREACTIVE) AND 1.2 AU/ML (NONREACTIVE). PER THE ALINITY I CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

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 REAGENT KIT LOT 71379FZ00. 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. REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I CMV IGG REAGENT AND COMPLAINT LOT RELATED TO THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED ON THE COMPLAINT LOT, WHICH CONCLUDED ACCEPTANCE CRITERIA WAS MET, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT LOT 71379FZ00 WAS IDENTIFIED.