KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Jan 28, 2021 · Event occurred Dec 1, 2020
Report 1119779-2021-00169 · MDR key 11248123
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
256045Catalog number
256045
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY BD POINT OF CARE QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ALLEGED FALSE POSITIVE WHEN USING THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR (REF# (B)(4)). BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THERE WAS NO LOT NUMBER DOCUMENTED IN THE SUBMISSION OF THIS COMPLAINT; THEREFORE NO INTERNAL INVESTIGATIONS CAN BE PERFORMED AND THE ISSUE CANNOT BE CONFIRMED. NO RETURNS WERE RECEIVED TO INVESTIGATE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS REPORTED. IN A FOLLOW-UP, CUSTOMER INDICATED THAT THE ISSUE WAS RESOLVED BY VORTEXING THE SPECIMEN AND RUNNING THE SPECIMEN WITHOUT DELAY. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD POINT OF CARE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH FALSE POSITIVE WHEN USING THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR (REF# (B)(4)). THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR 3 POSSIBLE FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A FALSE POSITIVE MAY LEAD TO TREATMENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE PATIENT CONSEQUENCE. A BIOFIRE RPP WAS USED TO CONFIRM 2 OF THE RESULTS AS FALSE POSITIVES. THERE WAS NO REPORT OF PATIENT IMPACT.
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. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR 3 POSSIBLE FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A FALSE POSITIVE MAY LEAD TO TREATMENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE PATIENT CONSEQUENCE. A BIOFIRE RPP WAS USED TO CONFIRM 2 OF THE RESULTS AS FALSE POSITIVES. THERE WAS NO REPORT OF PATIENT IMPACT.