ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I CMV IGG RESULTS 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. 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 80086FZ00. IN-HOUSE CLINICAL SPECIFICITY TESTING OF RETAINED KIT ALINITY I CMV IGG REAGENT LOT 80086FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CMV IGG ASSAY FOR LOT 80086FZ00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 6.0 AU/ML NONREACTIVE, >/= 6.0 AU/ML REACTIVE): ON (B)(6) 2025: CMV IGG RESULT AND CMV IGM RESULTS WERE BOTH NONREACTIVE WHEN TESTED ON THE ALINITY I PROCESSING MODULE. ON (B)(6) 2026, SID (B)(6): ALINITY I CMV IGG = 21.87 AU/ML (REACTIVE), OTHER TESTING PROVIDED: CMV IGM = NONREACTIVE. THE PATIENT HAD A NEW BLOOD SAMPLE DRAWN AT ANOTHER HOSPITAL. THE CMV IGG AND CMV IGM TESTS WERE PERFORMED ON A ROCHE PLATFORM, AND THOSE RESULTS WERE BOTH NONREACTIVE. ON (B)(6) 2026, SID (B)(6): REPEATED THE ORIGINAL SAMPLE, ALINITY I CMV IGG = 0.24 AU/ML (NONREACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 6.0 AU/ML NONREACTIVE, >/= 6.0 AU/ML REACTIVE): ON (B)(6) 2025: CMV IGG RESULT AND CMV IGM RESULTS WERE BOTH NONREACTIVE WHEN TESTED ON THE ALINITY I PROCESSING MODULE. ON (B)(6) 2026, SID (B)(6): ALINITY I CMV IGG = 21.87 AU/ML (REACTIVE). OTHER TESTING PROVIDED: CMV IGM = NONREACTIVE. THE PATIENT HAD A NEW BLOOD SAMPLE DRAWN AT ANOTHER HOSPITAL. THE CMV IGG AND CMV IGM TESTS WERE PERFORMED ON A ROCHE PLATFORM, AND THOSE RESULTS WERE BOTH NONREACTIVE. ON (B)(6) 2026, SID (B)(6): REPEATED THE ORIGINAL SAMPLE ALINITY I CMV IGG = 0.24 AU/ML (NONREACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.