KIT FLU A+B 30 TEST HOSPITAL VERITOR
Received Sep 22, 2022 · Event occurred Sep 7, 2022
Report 1119779-2022-01208 · MDR key 15465278
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
256041Catalog number
256041
Lot number
0225807
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
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 BY THE CUSTOMER THAT FALSE POSITIVE RESULTS ON KIT FLU A+B 30 TEST HOSPITAL VERITOR. THERE WAS TEN OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER IS CALLING TO REPORT FALSE POSITIVE RESULTS FOR 10/30 OF THEIR TESTS FROM THE 256041 PRODUCT. WALKED THROUGH WORKFLOW WITH CUSTOMER TO CLARIFY THAT EVERY STEP WAS PROPERLY COMPLETED. ALL PREVIOUS KITS WERE FINE ON DEVICE TODAY AND YESTERDAY FALSE POSITIVES WERE DETECTED. DOCTOR USED THE TEST ON STAFF WHO WERE NON SYMPTOMATIC TO TRIAL THE KIT (NO PCR BUT ALL SYMPTOMATIC) LOT NUMBER# 0225807".
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES CUSTOMER RECEIVED FALSE POSITIVE RESULTS FOR 10/30 OF THEIR TESTS WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041), BATCH NUMBER 0225807. 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. A BATCH HISTORY RECORD (BHR) REVIEW AND RETENTION TESTING WERE PERFORMED ON BATCH NUMBER PROVIDED. NO RELEVANT ISSUES WERE FOUND. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR FALSE POSITIVE. REVIEW OF RISK MANAGEMENT DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED COMPLAINT (FALSE POSITIVE) WAS ASSESSED AS SEVERITY S3 (REFERENCE LINE # 76) VIA DOCUMENT RA0002, REV 6. THIS COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT FALSE POSITIVE RESULTS ON KIT FLU A+B 30 TEST HOSPITAL VERITOR. THERE WAS TEN OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER IS CALLING TO REPORT FALSE POSITIVE RESULTS FOR 10/30 OF THEIR TESTS FROM THE 256041 PRODUCT. WALKED THROUGH WORKFLOW WITH CUSTOMER TO CLARIFY THAT EVERY STEP WAS PROPERLY COMPLETED. ALL PREVIOUS KITS WERE FINE ON DEVICE TODAY AND YESTERDAY FALSE POSITIVES WERE DETECTED. DOCTOR USED THE TEST ON STAFF WHO WERE NON SYMPTOMATIC TO TRIAL THE KIT (NO PCR BUT ALL SYMPTOMATIC) LOT NUMBER# 0225807".