BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Feb 3, 2021 · Event occurred Dec 14, 2020
Report 3006948883-2021-00182 · MDR key 11276749
Device
Generic name
Devices Detecting Influenza A, B, & C Virus Antigens
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Model number
256045Catalog number
256045
Lot number
0093792
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
MEDICAL DEVICE LOT #: 0093792 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR¿ 2 FALSE POSITIVE RESULTS WERE OBTAINED ON ASYMPTOMATIC PATIENTS. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
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 0093792. 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. 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 WHILE TESTING WITH BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR¿ 2 FALSE POSITIVE RESULTS WERE OBTAINED ON ASYMPTOMATIC PATIENTS. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.