KIT FLU A+B 30 TEST HOSPITAL VERITOR
Received Jul 20, 2021 · Event occurred Jun 20, 2021
Report 3006948883-2021-00814 · MDR key 12197316
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Model number
256041Catalog number
256041
Lot number
0040169
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
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE VIRAL PANEL WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT 5 FALSE POSITIVES. "
Additional Manufacturer Narrative
H.6. INVESTIGATION: THIS IS TO SUMMARIZE THE INVESTIGATION RESULTS FOR CUSTOMER COMPLAINTS ALLEGING FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING THE KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041) BATCH NUMBER 0040169. 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. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
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 HOSPITAL VERITOR 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE VIRAL PANEL WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT 5 FALSE POSITIVES. "