KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Mar 29, 2021 · Event occurred Mar 5, 2021
Report 1119779-2021-00578 · MDR key 11586394
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
256045Catalog number
256045
Lot number
0117717
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 0117717. 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. PICTURES WERE RETURNED AND INVESTIGATED. THE COMPLAINT CONFIRMED THE BACKGROUND OF THESE CARTRIDGES APPEAR TO HAVE VERTICAL LINE IN THE BACKGROUND FROM RETURNED PHOTOGRAPHS. 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 USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.MEDICAL DEVICE EXPIRATION DATE: UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.