BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ AT-HOME COVID-19 TEST

    MDR report key: 13552850 · Received February 17, 2022

    Report

    Report Number
    1119779-2022-00257
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    January 24, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EUA# (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 SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES THE BD VERITOR AT HOME COVID-19 TEST (MATERIAL # 256094), BATCH NUMBER 2006644, ¿HAD A NEGATIVE RESULT HOWEVER PCR RESULT WAS POSITIVE.¿ 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 TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. 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 NEGATIVE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2 WITH BD VERITOR ¿ AT-HOME COVID-19 TEST A FALSE NEGATIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS POSITIVE. THERE WAS NO REPORT OF USER IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER TOOK A PCR TEST AND TESTED POSITIVE BUT TESTED NEGATIVE WITH OUR TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2 WITH BD VERITOR ¿ AT-HOME COVID-19 TEST A FALSE NEGATIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS POSITIVE. THERE WAS NO REPORT OF USER IMPACT. EUA# 210417. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER TOOK A PCR TEST AND TESTED POSITIVE BUT TESTED NEGATIVE WITH OUR TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298756 BD VERITOR ¿ AT-HOME COVID-19 TEST NOT CLASSIFIED QKP BECTON, DICKINSON & CO. (SPARKS) 2006644

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown