ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

SECTION D4 - PRIMARY UDI NUMBER: CORRECTED FROM (B)(4). THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I CMV IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, 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 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 PREGNANT FEMALE PATIENTS. THE RESULTS DID NOT MATCH WITH THE PATIENTS¿ PREVIOUS RESULTS. THE CUSTOMER PERFORMED MOLECULAR TESTING AND BOTH PATIENTS CAME BACK NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 3: (B)(6) 2024 ALINITY I CMV IGG RESULT = 81.40 AU/ML (REACTIVE). OTHER RESULTS PROVIDED: ALINITY I CMV IGM RESULT = 19.78 INDEX (REACTIVE) ALINITY I CMV IGG AVIDITY RESULT = 54.55% (GRAYZONE) GENEPROOF MOLECULAR TEST RESULT = NEGATIVE PREVIOUS RESULTS WERE NEGATIVE FOR BOTH CMV IGG AND CMV IGM PATIENT 5: (B)(6) 2024 ALINITY I CMV IGG RESULTS = 112.90 AU /ML (REACTIVE), 104.6 AU/ML (REACTIVE), AND 101.7 AU/ML (REACTIVE) OTHER RESULTS PROVIDED: ALINITY I CMV IGM RESULTS = 0.36 INDEX (NONREACTIVE), 0.35 INDEX (NONREACTIVE) ALINITY I CMV IGG AVIDITY RESULT = 0.8% (LOW AVIDITY) GENEPROOF MOLECULAR TEST RESULT = NEGATIVE PREVIOUS RESULTS FROM (B)(6) 2023: BIOMERIEUX CMV IGG RESULT = <4 AU/ML (NONREACTIVE) BIOMERIEUX CMV IGM RESULT = 0.09 INDEX (NONREACTIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR TWO PREGNANT FEMALE PATIENTS. THE RESULTS DID NOT MATCH WITH THE PATIENTS¿ PREVIOUS RESULTS. THE CUSTOMER PERFORMED MOLECULAR TESTING AND BOTH PATIENTS CAME BACK NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: PATIENT 3: ON (B)(6) 2024 ALINITY I CMV IGG RESULT = 81.40 AU/ML (REACTIVE) OTHER RESULTS PROVIDED: ALINITY I CMV IGM RESULT = 19.78 INDEX (REACTIVE) ALINITY I CMV IGG AVIDITY RESULT = 54.55% (GRAYZONE) GENEPROOF MOLECULAR TEST RESULT = NEGATIVE PREVIOUS RESULTS WERE NEGATIVE FOR BOTH CMV IGG AND CMV IGM PATIENT 5: ON (B)(6) 2024 ALINITY I CMV IGG RESULTS = 112.90 AU /ML (REACTIVE), 104.6 AU/ML (REACTIVE), AND 101.7 AU/ML (REACTIVE) OTHER RESULTS PROVIDED: ALINITY I CMV IGM RESULTS = 0.36 INDEX (NONREACTIVE), 0.35 INDEX (NONREACTIVE) ALINITY I CMV IGG AVIDITY RESULT = 0.8% (LOW AVIDITY) GENEPROOF MOLECULAR TEST RESULT = NEGATIVE PREVIOUS RESULTS FROM (B)(6) 2023: BIOMERIEUX CMV IGG RESULT = <4 AU/ML (NONREACTIVE) BIOMERIEUX CMV IGM RESULT = 0.09 INDEX (NONREACTIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

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. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.