ALINITY I RUBELLA IGG REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID'S ARE (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P46-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4W02-22 , WITH 510K/PMA/BLA NUMBER K243168.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I RUBELLA IGG RESULT FOR A 32 YEAR OLD PREGNANT FEMALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 4.9 IU/ML (NONREACTIVE) ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 39.6 IU/ML (REACTIVE), REPEATS = 3.7 IU/ML AND 4.2 IU/ML (NONREACTIVE), REPEAT ON ANOTHER ALINITY = 4.2 IU/ML (NONREACTIVE) ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 3.9 IU/ML (NONREACTIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I RUBELLA IGG REAGENT LOT: 73126FZ00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF FIELD DATA SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT FOR NONREACTIVE RESULTS IS COMPARABLE WITH OTHER LOTS IN THE FIELD CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I RUBELLA IGG REAGENT LOT: 73126FZ00.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I RUBELLA IGG RESULT FOR A 32-YEAR-OLD PREGNANT FEMALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 4.9 IU/ML (NONREACTIVE). ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 39.6 IU/ML (REACTIVE), REPEATS = 3.7 IU/ML AND 4.2 IU/ML (NONREACTIVE), REPEAT ON ANOTHER ALINITY = 4.2 IU/ML (NONREACTIVE). ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 3.9 IU/ML (NONREACTIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.