KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Received Jun 30, 2021 · Event occurred Jun 3, 2021
Report 3006948883-2021-00719 · MDR key 12097010
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
0154760
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 PHYSICIAN VERITOR A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. AN ACCU REFERENCE LAB TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " CUSTOMER REPORTS SEVERAL FALSE POSITIVES OVER THE PAST MONTH WHEN USING THE FLU KIT. INITIAL RESULTS WERE FLU A POSITIVE AND FLU B NEGATIVE. EACH SAMPLE WAS CONFIRMED WITH THE ACCU REFERENCE MEDICAL LAB'S RESPIRATORY PANEL AND TESTED NEGATIVE FOR FLU A YET POSITIVE FOR RHINOVIRUS/ENTEROVIRUS."
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MN# 256045), BATCH NUMBER 0154760. 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.
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 A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. AN ACCU REFERENCE LAB TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " CUSTOMER REPORTS SEVERAL FALSE POSITIVES OVER THE PAST MONTH WHEN USING THE FLU KIT. INITIAL RESULTS WERE FLU A POSITIVE AND FLU B NEGATIVE. EACH SAMPLE WAS CONFIRMED WITH THE ACCU REFERENCE MEDICAL LAB'S RESPIRATORY PANEL AND TESTED NEGATIVE FOR FLU A YET POSITIVE FOR RHINOVIRUS/ENTEROVIRUS."