ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

SECTION A1 - PATIENT IDENTIFIER: SIDS = (B)(6) . THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY I CMV IGG, LIST NUMBER 07P42-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24/-33. THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I CMV IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. ADDITIONALLY, IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER 56520FN00 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 THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET WHICH INDICATES THE LOT IS PERFORMING AS EXPECTED. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CMV IGG REAGENT FOR LOT 56520FN00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR TWO PATIENTS. THE SAMPLES WERE REPEATED AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID (B)(6) , INITIAL RESULT = 6.5 AU/ML (REACTIVE) REPEAT RESULT = 0 AU/ML (NONREACTIVE) REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 0 AU/ML (NONREACTIVE) ON (B)(6) 2024, SID (B)(6), INITIAL RESULT = 19.2 AU/ML (REACTIVE) REPEAT RESULT = 0 AU/ML (NONREACTIVE) REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 0.2 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.