BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 13214950 · Received January 10, 2022

    Report

    Report Number
    1119779-2021-02129
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    October 7, 2021
    Report Date
    June 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    UDI-DI
    00382902560661
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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

    (B)(4). 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: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE RESULTS WHEN USING BD KIT VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 1153341. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE BATCH NUMBER PROVIDED. A CONVERSATION WAS CONDUCTED BETWEEN THE CUSTOMER AND BD MEDICAL AFFAIRS ABOUT SENSITIVITY LEVELS AND TESTING OF ASYMPTOMATIC PATIENTS. THE CUSTOMER UNDERSTOOD THAT CLINICAL EVIDENCE SUGGESTS THAT THERE WILL BE LOWER SENSITIVITY AMONG ASYMPTOMATIC PEOPLE. THE CUSTOMER UNDERSTOOD THE ISSUE, BUT WILL BE PROCEEDING WITH AN OFF LABEL VERIFICATION INVOLVING ASYMPTOMATIC PATIENTS. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. NO TREND AGAINST FALSE NEGATIVE WAS IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR FALSE NEGATIVE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, A FALSE NEGATIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED, AND THE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE NO. (B)(6) WAS TESTED BY RT-PCR FOR SARS-COV-2 (NASOPHARYNX AND OROPHARYNX SWAB IN 0.9% SALINE SOLUTION), WITH A POSITIVE RESULT AND CTS OF 22.3 FOR THE N2 GENE AND 20.5 FOR THE GENE E (GENEXPERT). IT WAS THEN TESTED ON THE BD VERITOR SARS-COV-2, WITH A NEGATIVE RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, A FALSE NEGATIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED, AND THE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE NO. (B)(6) WAS TESTED BY RT-PCR FOR SARS-COV-2 (NASOPHARYNX AND OROPHARYNX SWAB IN 0.9% SALINE SOLUTION), WITH A POSITIVE RESULT AND CTS OF 22.3 FOR THE N2 GENE AND 20.5 FOR THE GENE E (GENEXPERT). IT WAS THEN TESTED ON THE BD VERITOR SARS-COV-2, WITH A NEGATIVE RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, A FALSE NEGATIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED, AND THE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #(B)(6) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE NO. (B)(6) WAS TESTED BY RT-PCR FOR SARS-COV-2 (NASOPHARYNX AND OROPHARYNX SWAB IN 0.9% SALINE SOLUTION), WITH A POSITIVE RESULT AND CTS OF 22.3 FOR THE N2 GENE AND 20.5 FOR THE GENE E (GENEXPERT). IT WAS THEN TESTED ON THE BD VERITOR SARS-COV-2, WITH A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179391 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 256066 1153341 00382902560661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown