BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT RSV 30 TEST PHYSICIAN VERITOR

    MDR report key: 14639503 · Received June 8, 2022

    Report

    Report Number
    1119779-2022-00838
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    April 25, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GQG
    UDI-DI
    00382902560388
    PMA / PMN Number
    K132456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 1285854 WITH EXPIRATION DATE 20-SEP-2024 WAS REPORTED, HOWEVER, THIS IS NOT A LOT NUMBER MANUFACTURED FOR THE REPORTED CATALOG NUMBER. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES THE BD VERITOR AT HOME COVID-19 TEST (MATERIAL # 256094), BATCH NUMBER UNKNOWN, ¿HAD A POSITIVE RESULT HOWEVER THE TEST FROM PARKWAY LAB WAS NEGATIVE.¿ BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL 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 RETURN TESTING WERE PERFORMED WITH NO ISSUES IDENTIFIED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR FALSE POSITIVE. 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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES THE BD VERITOR AT HOME COVID-19 TEST (MATERIAL # 256094), BATCH NUMBER UNKNOWN, ¿HAD A POSITIVE RESULT HOWEVER THE TEST FROM PARKWAY LAB WAS NEGATIVE.¿ BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL 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 RETURN TESTING WERE PERFORMED WITH NO ISSUES IDENTIFIED. INITIALLY BATCH NUMBER WAS UNKNOWN BUT RETURN SAMPLE FROM CUSTOMER CONFIRM BATCH NUMBER IS 1294741. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE KIT RSV 30 TEST PHYSICIAN VERITOR, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT 1 ERRONEOUS RESULT WHEN PERFORMING RSV TEST. ¿ WAS INDIVIDUAL SYMPTOMATIC OR ASYMPTOMATIC? THE PATIENTS HAD CONGESTIONS AND RUNNY NOSES AND AFEBRILES. ¿ HOW WAS IT DETERMINED TO BE DISCREPANT? WE SENT ANOTHER SAMPLES TO THE LAB (PARKWAY LABS) THEY RUN IT FOR TWO DAYS IN THERE SYSTEM AND IT CAME BACK WITH A NEGATIVE RESULT. ¿ COMPARISON TO ANOTHER METHOD? PARKWAY LABS METHOD VS BD VERITOR METHOLOGY AND BOTH USES NASALPHARYNGEAL SWABS TO OBTAIN THE SAMPLES. ¿ WAS THE CARTRIDGE RERUN (RE-READ)? YES, JUST TO MAKE SURE THAT WE HAVE THE SAME RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE KIT RSV 30 TEST PHYSICIAN VERITOR, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT 1 ERRONEOUS RESULT WHEN PERFORMING RSV TEST WAS INDIVIDUAL SYMPTOMATIC OR ASYMPTOMATIC? THE PATIENTS HAD CONGESTIONS AND RUNNY NOSES AND AFEBRILES HOW WAS IT DETERMINED TO BE DISCREPANT?¿ WE SENT ANOTHER SAMPLES TO THE LAB (PARKWAY LABS) THEY RUN IT FOR TWO DAYS IN THERE SYSTEM AND IT CAME BACK WITH A NEGATIVE RESULT. COMPARISON TO ANOTHER METHOD? PARKWAY LABS METHOD VS BD VERITOR METHOLOGY AND BOTH USES NASOPHARYNGEAL SWABS TO OBTAIN THE SAMPLES. WAS THE CARTRIDGE RERUN (RE-READ)? YES JUST TO MAKE SURE THAT WE HAVE THE SAME RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE KIT RSV 30 TEST PHYSICIAN VERITOR, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT 1 ERRONEOUS RESULT WHEN PERFORMING RSV TEST. WAS INDIVIDUAL SYMPTOMATIC OR ASYMPTOMATIC? THE PATIENTS HAD CONGESTIONS AND RUNNY NOSES AND AFEBRILES. HOW WAS IT DETERMINED TO BE DISCREPANT? WE SENT ANOTHER SAMPLES TO THE LAB (PARKWAY LABS) THEY RUN IT FOR TWO DAYS IN THERE SYSTEM AND IT CAME BACK WITH A NEGATIVE RESULT. COMPARISON TO ANOTHER METHOD? PARKWAY LABS METHOD VS BD VERITOR METHOLOGY AND BOTH USES NASALPHARYNGEAL SWABS TO OBTAIN THE SAMPLES. WAS THE CARTRIDGE RERUN (RE-READ)? YES JUST TO MAKE SURE THAT WE HAVE THE SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028067 KIT RSV 30 TEST PHYSICIAN VERITOR ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG BECTON, DICKINSON & CO. (SPARKS) 256038 SEE H10 00382902560388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown