BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Dec 6, 2021 · Event occurred Oct 31, 2021
Report 1119779-2021-01917 · MDR key 12937547
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
256045Catalog number
256045
Lot number
0051984
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION: 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), INVALID BATCH NUMBER 0051984 WAS REPORTED. 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 COULD NOT BE PERFORMED AS INVALID BATCH NUMBER 0051984 WAS PROVIDED. PROVIDED BATCH NUMBER 0051984 IS INVALID BECAUSE THE BATCH IS NOT ASSOCIATED WITH MATERIAL 256045. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER SAYS SHE HAS BEEN GETTING FP TESTS ON THE RAPID DETECTION OF FLU A/B TESTS".
Additional Manufacturer Narrative
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER SAYS SHE HAS BEEN GETTING FP TESTS ON THE RAPID DETECTION OF FLU A/B TESTS"