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: SAMPLE ID IS (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: SAMPLE ID (B)(6) INITIAL RESULT WAS 26.868 AND REPEAT RESULTS WERE 0.033, 0.308, & 0.384 (REFERENCE: = 6 AU/ML IS REACTIVE) PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6), INITIAL RESULT WAS 26.868 AND REPEAT RESULTS WERE 0.033, 0.308, & 0.384 (REFERENCE: = 6 AU/ML IS REACTIVE). PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

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. TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY RELATED TRENDS REGARDING COMMONALITIES FOR LOT NUMBER AND COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH COMPLAINT LOT AND THE COMPLAINT ISSUE. IN HOUSE TESTING WAS CONDUCTED ON LOT NUMBER 64302FZ00, AND THE TESTING DETERMINED THE SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.