KIT FLU VERITOR SYSTEM 30 TEST JAPAN

Description of Event or Problem

IT WAS REPORTED WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN, THERE WAS A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

E.1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN (MATERIAL # 256052), BATCH NUMBER 2314804. ACCORDING TO THE CUSTOMER'S INFORMATION, POSITIVE RESULTS FOR FLU WERE GIVEN IN ABOUT 80% OF NEGATIVE SAMPLES, AND 10% OF THEM WERE INDICATED AS FLU A AND B SIMULTANEOUSLY POSITIVE. TAMIFLU WAS ADMINISTERED DUE TO THE POSITIVE RESULTS. THE SALES REPRESENTATIVE CONFIRMED THAT THE CUSTOMER USED SWABS FROM SIEMENS AG (PHOTOS ATTACHED) INSTEAD OF THE ENCLOSED GENUINE BD SWABS. THE CUSTOMER WONDERS IF THERE IS A POSSIBILITY FALSE POSITIVE MAY BE CAUSED BY USAGE OF SWABS MADE BY OTHER COMPANIES. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUES WERE FOUND. TESTING WAS PERFORMED ON THE PRODUCT RETURNED. THE DEVICES TESTED HAD NORMAL INTENDED RESULTS. NO ISSUES WERE OBSERVED. THE CUSTOMER ALSO PROVIDED THE PHOTOGRAPH OF TEST CARTRIDGE, WHICH SHOWED LINES AT CONTROL AREA, FLU A AND B. THE REPORTED ISSUE WAS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE. IN THIS CASE, THE CUSTOMER USED SWABS FROM A DIFFERENT MANUFACTURER INSTEAD OF BD SWABS, WHICH IS NOT RECOMMENDED. THE CUSTOMERS ARE INSTRUCTED TO USE ONLY COMPONENTS ENCLOSED WITH THE KIT TO PERFORM THE TEST. THE ROOT CAUSE TRACED TO THE USER. CURRENTLY NO ADVERSE TRENDS WERE IDENTIFIED FOR FALSE POSITIVE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.