KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Jun 15, 2021 · Event occurred Apr 29, 2021
Report 3006948883-2021-00689 · MDR key 12005442
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Model number
256045Catalog number
256045
Lot number
0076570
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 MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 0076570. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: " IT WAS REPORTED THAT FALSE NEGATIVE RESULTS ON THEIR VERITOR FLU A+B KIT. ".
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.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: " IT WAS REPORTED THAT FALSE NEGATIVE RESULTS ON THEIR VERITOR FLU A+B KIT. "