ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER REFERENCE = 6.0 AU/ML IS REACTIVE SAMPLE ID (B)(6): ON (B)(6) 2024, INITIAL RESULT WAS 67.6 AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.05 AU/ML. SAMPLE ID (B)(6): ON (B)(6) 2024, INITIAL RESULT WAS 18.2AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.3 AU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33 WITH 510K/PMA/BLA NUMBER K220949. 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. 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ALINITY I CMV IGG REAGENT HOWEVER THE SEARCH DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH CONCLUDED ALL SPECIFICATIONS WERE MET AND THE COMPLAINT LOT 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 64302FZ00 IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER REFERENCE = 6.0 AU/ML IS REACTIVE. SAMPLE ID (B)(6): ON (B)(6) 2024, INITIAL RESULT WAS 67.6 AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.05 AU/ML. SAMPLE ID (B)(6) : ON (B)(6) 2024, INITIAL RESULT WAS 18.2AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.3 AU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

A1: PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID'S IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.