BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ AT-HOME COVID-19 TEST

    MDR report key: 13579808 · Received February 22, 2022

    Report

    Report Number
    1119779-2022-00280
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 28, 2022
    Report Date
    July 29, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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

    THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES THE ¿CUSTOMER RECEIVED DISCREPANT RESULTS¿ USING THE BD VERITOR AT HOME COVID-19 TESTS (MATERIAL # 256094), BATCH NUMBER 1356058; ¿ONE TEST WAS POSITIVE AND ONE TEST WAS NEGATIVE; ALSO TESTED NEGATIVE WITH BINAX TEST.¿ 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 DISCREPANT RESULTS. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2 WITH A BD VERITOR ¿ AT-HOME COVID-19 TEST THE CONSUMER RECEIVED A POSITIVE RESULT. CUSTOMER RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER RECEIVED A POSITIVE AND RETESTED NEGATIVE 15 MINUTES LATER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2 WITH A BD VERITOR ¿ AT-HOME COVID-19 TEST THE CONSUMER RECEIVED A POSITIVE RESULT. CUSTOMER RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT. EUA# 210417. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER RECEIVED A POSITIVE AND RETESTED NEGATIVE 15 MINUTES LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147050 BD VERITOR ¿ AT-HOME COVID-19 TEST NOT CLASSIFIED QKP BECTON, DICKINSON & CO. (SPARKS) 1356058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown