BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ AT-HOME COVID-19 TEST

    MDR report key: 15471018 · Received September 23, 2022

    Report

    Report Number
    1119779-2022-01227
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES ¿DISCREPANT RESULTS¿ USING THE BD VERITOR AT HOME COVID-19 TEST (MATERIAL # 256094), BATCH NUMBER 2021489. 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. BATCH HISTORY RECORD REVIEW AND RETAIN SAMPLE 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.

    Additional Manufacturer Narrative · 0

    ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, MD WAS USED AS A PLACE HOLDER. PMA/510K #: NA. EUA#: (B)(4). 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 · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED DISCREPANT RESULTS WITH BD VERITOR ¿ AT-HOME COVID-19 TEST. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER CALLED ASKING ABOUT THE LINES ON HER TEST STICK AND AFTER I ANSWERED HER QUESTION SHE STATED THAT SHE TOOK A DIFFERENT BRAND YESTERDAY AND GOT A POSITIVE RESULT AND THEN GOT A NEGATIVE RESULT TODAY FROM OUR TEST".

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED DISCREPANT RESULTS WITH BD VERITOR ¿ AT-HOME COVID-19 TEST. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER CALLED ASKING ABOUT THE LINES ON HER TEST STICK AND AFTER I ANSWERED HER QUESTION SHE STATED THAT SHE TOOK A DIFFERENT BRAND YESTERDAY AND GOT A POSITIVE RESULT AND THEN GOT A NEGATIVE RESULT TODAY FROM OUR TEST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2828626 BD VERITOR ¿ AT-HOME COVID-19 TEST NOT CLASSIFIED QKP BECTON, DICKINSON & CO. (SPARKS) 2021489

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown