ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT, WHICH WAS INCONSISTENT WITH THE PATIENT¿S HISTORY. THE CUSTOMER REQUESTED A NEW SAMPLE FROM THE PATIENT, WHICH GENERATED A NONREACTIVE RESULT. A REPEAT OF THE FIRST SAMPLE ALSO GENERATED A NONREACTIVE RESULT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6) (FIRST SAMPLE) RESULT = 224.9 AU/ML (REACTIVE). (B)(6) 2025, SID (B)(6) (FIRST SAMPLE) REPEAT RESULT = 0.2 AU/ML (NONREACTIVE). (B)(6) 2025 (SECOND SAMPLE) RESULT = 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, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF A RETAINED REAGENT KITS. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 64269FZ00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 64269FZ00 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. FURTHERMORE, CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED REAGENT KIT OF ALINITY I CMV IGG REAGENT LOT 64269FZ00. ALL SPECIFICATIONS WERE MET, WHICH INDICATES THE LOT IS PERFORMING AS EXPECTED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT, LOT NUMBER 64269FZ00, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT, WHICH WAS INCONSISTENT WITH THE PATIENT¿S HISTORY. THE CUSTOMER REQUESTED A NEW SAMPLE FROM THE PATIENT, WHICH GENERATED A NONREACTIVE RESULT. A REPEAT OF THE FIRST SAMPLE ALSO GENERATED A NONREACTIVE RESULT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) (FIRST SAMPLE) RESULT = 224.9 AU/ML (REACTIVE), ON (B)(6) 2025 SID (B)(6) (FIRST SAMPLE) REPEAT RESULT = 0.2 AU/ML (NONREACTIVE), ON (B)(6) 2025 (SECOND SAMPLE) RESULT = 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

SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-32 THAT HAS A SIMILAR 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.