KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING WITH KIT FLU A+B 30 TEST PHYSICIAN VERITOR A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT WAS RETESTED USING A DIFFERENT KIT AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT SHE OBTAINED 5 POSITIVE RESULTS ( TEST KIT FLU A+B 30 TEST PHYSICIAN VERITOR WITH KIT LOT # 0070254 ) ON 5 DIFFERENT INDIVIDUALS; SHE TESTED ONE OF THE 5 POSITIVE PATIENTS USING ANOTHER 256045 TEST KIT ( KIT LOT # 9346065) AND SHE OBTAINED A NEGATIVE FLU A + B ) RESULT. THE CUSTOMER DID NOT PERFORM PCR ON ANY OF THE PATIENTS. CUSTOMER IS UNABLE TO TRACK PATIENTS 1-4 TO SEE IF THERE ARE ANY CONFLICTING RESULTS UPON RETEST. THE ONLY PATIENT THAT WAS RE-TESTED IN ANY WAY WAS PATIENT #5. SO THE CUSTOMER ONLY HAS 1 DISCREPANT RESULT. THE OTHER 4 PATIENTS ARE CONTEXT AND THERE ARE NO CONFLICTING TESTS INDICATING PATIENTS 1-4 HAVE DISCREPANT RESULTS.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MN# 256045), BATCH NUMBER 9346065. 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. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE TESTING WITH KIT FLU A+B 30 TEST PHYSICIAN VERITOR A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENT WAS RETESTED USING A DIFFERENT KIT AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT SHE OBTAINED 5 POSITIVE RESULTS ( TEST KIT FLU A+B 30 TEST PHYSICIAN VERITOR WITH KIT LOT # 0070254 ) ON 5 DIFFERENT INDIVIDUALS; SHE TESTED ONE OF THE 5 POSITIVE PATIENTS USING ANOTHER 256045 TEST KIT ( KIT LOT # 9346065) AND SHE OBTAINED A NEGATIVE FLU A + B ) RESULT. THE CUSTOMER DID NOT PERFORM PCR ON ANY OF THE PATIENTS. CUSTOMER IS UNABLE TO TRACK PATIENTS 1-4 TO SEE IF THERE ARE ANY CONFLICTING RESULTS UPON RETEST. THE ONLY PATIENT THAT WAS RE-TESTED IN ANY WAY WAS PATIENT #5. SO THE CUSTOMER ONLY HAS 1 DISCREPANT RESULT. THE OTHER 4 PATIENTS ARE CONTEXT AND THERE ARE NO CONFLICTING TESTS INDICATING PATIENTS 1-4 HAVE DISCREPANT RESULTS.