KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT RAPID DETECTION OF KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 0015987. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULT COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH KIT FLU A+B 30 TEST PHYSICIAN VERITOR, A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TEST WAS PERFORMED ON BD VERITOR ¿ SARS-COV-2 & FLU A+B AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 256045 ERRONEOUS RESULTS.

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH KIT FLU A+B 30 TEST PHYSICIAN VERITOR, A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TEST WAS PERFORMED ON BD VERITOR ¿ SARS-COV-2 & FLU A+B AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 256045 ERRONEOUS RESULTS.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.