BD KIT FLU VERITOR SYSTEM 30 TEST JAPAN

Additional Manufacturer Narrative

B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES A FALSE NEGATIVE WHEN USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN (MATERIAL#: 256052), BATCH NUMBER 3263738. THE CUSTOMER REPORTED THAT THE SENSITIVITY OF THE PRODUCT SEEMS TO HAVE DROPPED, AND THEY BELIEVE THAT IT IS NO LONGER POSSIBLE TO YIELD A POSITIVE RESULT. THE CUSTOMER HAS NOTED THAT THEY ARE ABLE TO RECEIVE A POSITIVE RESULT WITH OTHER KITS, BUT WITH VERITOR, A POSITIVE RESULT CANNOT BE RECEIVED. THEY ALSO NOTED THAT THE CONTROL LINE HAS BECOME THIN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE NEGATIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. 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.

Description of Event or Problem

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