KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Feb 28, 2022 · Event occurred Jan 31, 2022
Report 3006948883-2022-00042 · MDR key 13624939
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
0304672
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
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 TESTING WITH THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR, INCORRECT RESULTS WERE OBTAINED. 5 PATIENTS TESTED POSITIVE FOR BOTH FLU A AND FLU B. FALSE RESULTS WERE CONFIRMED VIA PCR TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE 5 PATIENTS TESTED POSITIVE FOR BOTH FLU A AND FLU B ON VER 256045.
Additional Manufacturer Narrative
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 TESTING WITH THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR, INCORRECT RESULTS WERE OBTAINED. 5 PATIENTS TESTED POSITIVE FOR BOTH FLU A AND FLU B. FALSE RESULTS WERE CONFIRMED VIA PCR TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE 5 PATIENTS TESTED POSITIVE FOR BOTH FLU A AND FLU B ON VER 256045.
Additional Manufacturer Narrative
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES DISCREPANT RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 0304672. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULTS 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. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT WHILE TESTING WITH THE KIT FLU A+B 30 TEST PHYSICIAN VERITOR, INCORRECT RESULTS WERE OBTAINED. 5 PATIENTS TESTED POSITIVE FOR BOTH FLU A AND FLU B. FALSE RESULTS WERE CONFIRMED VIA PCR TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE 5 PATIENTS TESTED POSITIVE FOR BOTH FLU A AND FLU B ON VER 256045