BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 3RD OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION.: B5: IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 3RD OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 3RD OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041), BATCH NUMBERS 2222483 & 2213636. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FROM 8 DIFFERENT PATIENT SAMPLES AT TWO LAB SITES. THIS COMPLAINT PERTAINS TO 4 FALSE POSITIVE RESULTS, WITH 2 OCCURRING FOR EACH OF THE BATCH NUMBERS 2222483 & 2213636 AT (B)(6) SITE. THE CUSTOMER STATED THAT PCR CONFIRMATORY TESTING WAS PERFORMED BY THE STATE LAB, ALL OF WHICH TESTED NEGATIVE FOR FLU A ON PCR BUT POSITIVE ON THE VERITOR. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. A BATCH HISTORY RECORD (BHR) REVIEW AND RETENTION TESTING WERE PERFORMED ON THE BATCH NUMBERS PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE IDENTIFIED. NO PHOTOS OR PHYSICAL SAMPLES WERE RETURNED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR FALSE POSITIVE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 1ST OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.