BD KIT FLU A+B 30 TEST HOSPITAL VERITOR¿

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD KIT FLU A+B 30 TEST HOSPITAL VERITOR¿ A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING PERFORMED USING PCR TEST METHOD AND WAS NEGATIVE. RESULT WAS NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULT NOT CONFIRMED BY REAL TIME PCR. FALSE POSITIVE RESULT FOR A CLINICAL SAMPLE, NASOPHARYNGEAL SWAB IN NACL 0,9% FROM A PATIENT BORN IN 1994 NOT CONFIRMED BY REAL TIME PCR. VISUAL INSPECTION OF THE VERITOR DEVICE SHOWED A VERY LIGHT LINE WHICH WAS INTERPRETED BY THE VERITOR PLUS ANALYSE AS POSITIVE. THE SAME SAMPLE WAS TESTED FALSE POSITIVE FOR RSV, ALSO NOT CONFIRMED BY REAL TIME PCR. PATIENT WAS SARS-COV 2 NEGATIVE THIS CUSTOMER WOULD LIKE TO KNOW WHICH SUBSTANCES AND/OR OTHER RESPIRATORY PATHOGENS CAUSE CROSS REACTION WITH OUR DEVICE RESULTING IN FALSE POSITIVE RESULTS. NO INCORRECT RESULTS WERE REPORTED ¿ SAME SAMPLE (FROM THE SAME PATIENT) WAS FALSE POSITIVE FOR FLUA AND RSV ¿ ONLY WHEN A SAMPLE IS POSITIVE FOR BOTH FLUA & RSV , WITH A WEAK LINE, A PCR TEST IS PERFORMED FOR CONFIRMATION. ¿ ALSO FOR THIS CASE , THE CLINICAL SYMPTONS WERE NOT CORRELATING WITH A POSITIVE RESULT FOR FLUA AND RSV.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041), BATCH NUMBER 0143979. 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 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 H10.

Additional Manufacturer Narrative

DATE OF BIRTH: PATIENT¿S BIRTHDAY FULL BIRTHDAY WAS NOT PROVIDED, ONLY THE YEAR. ON (B)(6) WAS USED AND AGE CALCULATED BASED OFF THIS DATE. 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 USING BD KIT FLU A+B 30 TEST HOSPITAL VERITOR¿ A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING PERFORMED USING PCR TEST METHOD AND WAS NEGATIVE. RESULT WAS NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULT NOT CONFIRMED BY REAL TIME PCR. FALSE POSITIVE RESULT FOR A CLINICAL SAMPLE, NASOPHARYNGEAL SWAB IN NACL 0,9% FROM A PATIENT BORN IN (B)(6) NOT CONFIRMED BY REAL TIME PCR. VISUAL INSPECTION OF THE VERITOR DEVICE SHOWED A VERY LIGHT LINE WHICH WAS INTERPRETED BY THE VERITOR PLUS ANALYSE AS POSITIVE. THE SAME SAMPLE WAS TESTED FALSE POSITIVE FOR RSV, ALSO NOT CONFIRMED BY REAL TIME PCR. PATIENT WAS SARS-COV 2 NEGATIVE. THIS CUSTOMER WOULD LIKE TO KNOW WHICH SUBSTANCES AND/OR OTHER RESPIRATORY PATHOGENS CAUSE CROSS REACTION WITH OUR DEVICE RESULTING IN FALSE POSITIVE RESULTS. NO INCORRECT RESULTS WERE REPORTED. SAME SAMPLE (FROM THE SAME PATIENT) WAS FALSE POSITIVE FOR FLUA AND RSV. ONLY WHEN A SAMPLE IS POSITIVE FOR BOTH FLUA & RSV , WITH A WEAK LINE, A PCR TEST IS PERFORMED FOR CONFIRMATION. ALSO FOR THIS CASE , THE CLINICAL SYMPTONS WERE NOT CORRELATING WITH A POSITIVE RESULT FOR FLUA AND RSV.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD KIT FLU A+B 30 TEST HOSPITAL VERITOR¿ A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING PERFORMED USING PCR TEST METHOD AND WAS NEGATIVE. RESULT WAS NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULT NOT CONFIRMED BY REAL TIME PCR. FALSE POSITIVE RESULT FOR A CLINICAL SAMPLE, NASOPHARYNGEAL SWAB IN NACL 0,9% FROM A PATIENT BORN IN (B)(6) NOT CONFIRMED BY REAL TIME PCR. VISUAL INSPECTION OF THE VERITOR DEVICE SHOWED A VERY LIGHT LINE WHICH WAS INTERPRETED BY THE VERITOR PLUS ANALYSE AS POSITIVE. THE SAME SAMPLE WAS TESTED FALSE POSITIVE FOR RSV, ALSO NOT CONFIRMED BY REAL TIME PCR. PATIENT WAS SARS-COV 2 NEGATIVE. THIS CUSTOMER WOULD LIKE TO KNOW WHICH SUBSTANCES AND/OR OTHER RESPIRATORY PATHOGENS CAUSE CROSS REACTION WITH OUR DEVICE RESULTING IN FALSE POSITIVE RESULTS. NO INCORRECT RESULTS WERE REPORTED. SAME SAMPLE (FROM THE SAME PATIENT) WAS FALSE POSITIVE FOR FLUA AND RSV. ONLY WHEN A SAMPLE IS POSITIVE FOR BOTH FLUA & RSV , WITH A WEAK LINE, A PCR TEST IS PERFORMED FOR CONFIRMATION. ALSO FOR THIS CASE , THE CLINICAL SYMPTONS WERE NOT CORRELATING WITH A POSITIVE RESULT FOR FLUA AND RSV.

Additional Manufacturer Narrative

DATE OF BIRTH: PATIENT¿S BIRTHDAY FULL BIRTHDAY WAS NOT PROVIDED, ONLY THE YEAR. ON (B)(6) WAS USED AND AGE CALCULATED BASED OFF THIS DATE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.