ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.  THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24/-33 AND A 510K/PMA/BLA NUMBER OF K220949.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 6.00 AU/ML): SAMPLE ID (B)(6) INITIAL RESULT = 12.6 AU\ML, REPEAT RESULT = 13.2 AU\ML SAME PATIENT, DIFFERENT SAMPLE. SAMPLE ID (B)(6) INITIAL RESULT ON INSTRUMENT (B)(6) = 12.3 AU/ML, REPEAT RESULT ON INSTRUMENT (B)(6) = 12.4 AU/ML VIRAL LOAD = NEGATIVE CMV IGG RESULT AT ANOTHER LAB = 2.11 (CUT-OFF POINT 1.0) NO IMPACT TO PATIENT MANAGEMENT WAS 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, IN HOUSE TESTING OF A RETAINED REAGENT KIT, AND RETURN SAMPLE ANALYSIS WAS COMPLETED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. 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 67106FZ00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS RELATING TO THE COMPLAINT UNDER REVIEW. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET INDICATING THAT LOT 67106FZ00 IS PERFORMING ACCEPTABLY. THE RETURNED SAMPLES WERE TESTED USING AN IN-HOUSE RETAINED KIT OF ALINITY I CMV IGG REAGENT LOT 67106FZ00. THE REACTIVE CMV IGG RESULTS THAT WERE OBTAINED AT THE CUSTOMERS SITE WERE REPEATED INHOUSE AND WERE INTERPRETED AS NOT BEING FALSE POSITIVE AS PER SITE DECISION TABLES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. A MALFUNCTION WAS NOT IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. BASED ON THE INVESTIGATION THE ALINITY I CMV IGG REAGENT LOT 67106FZ00 IS PERFORMING AS INTENDED. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 6.00 AU/ML): SAMPLE ID (B)(6), INITIAL RESULT = 12.6 AU\ML, REPEAT RESULT = 13.2 AU\ML. SAME PATIENT, DIFFERENT SAMPLE. SAMPLE ID (B)(6), INITIAL RESULT ON INSTRUMENT (B)(6) = 12.3 AU/ML, REPEAT RESULT ON INSTRUMENT (B)(6) = 12.4 AU/ML. VIRAL LOAD = NEGATIVE CMV IGG RESULT AT ANOTHER LAB = 2.11 (CUT-OFF POINT 1.0). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.