ALINITY I CMV IGG REAGENT KIT

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

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE = 6.0 AU/ML REACTIVE. PATIENT 1: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 15.2 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. NO FURTHER PATIENT INFORMATION PROVIDED. PATIENT 2: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 67.5 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. PATIENT 2 INFORMATION: PATIENT IS PREGNANT AND HISTORICAL VALUE FROM (B)(6) 2025 WAS < 1.1. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION CAN BE FOUND IN SECTION B5.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE = 6.0 AU/ML REACTIVE. PATIENT 1: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 15.2 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. NO FURTHER PATIENT INFORMATION PROVIDED. PATIENT 2: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 67.5 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. PATIENT 2 INFORMATION: PATIENT IS PREGNANT AND HISTORICAL VALUE FROM (B)(6) 2025 WAS < 1.1 PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL DATA: PATIENT 3: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 144.5 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. RESULTS GENERATED FROM LOT 71379FZ00.

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, 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. REVIEW OF TRACKING AND TRENDING FOR THE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I CMV IGG REAGENT AND COMPLAINT LOT RELATED TO THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED ON THE COMPLAINT LOT, WHICH CONCLUDED ACCEPTANCE CRITERIA WAS MET, AND THE PRODUCT 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 71379FZ00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE = 6.0 AU/ML REACTIVE. PATIENT 1: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 15.2 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. NO FURTHER PATIENT INFORMATION PROVIDED. PATIENT 2: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 67.5 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. PATIENT 2 INFORMATION: PATIENT IS PREGNANT AND HISTORICAL VALUE FROM (B)(6) 2025 WAS < 1.1 PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL DATA: PATIENT 3: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 144.5 (REACTIVE). REPEAT RESULTS WERE < 1.1 AND < 1.1. RESULTS GENERATED FROM LOT 71379FZ00.